# EUR-Lex - 52013PC0471 - EN

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# 52013PC0471

**Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of the laws of the Member States relating to making available on the market of pressure equipment (Recast) /* COM/2013/0471 final - 2013/0221 (COD) */**

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EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

General context, reasons for and
objectives of this proposal

This proposal intends to align Directive
97/23/EC on pressure equipment to the ‘goods package’ adopted in
2008 and in particular to Decision No 768/2008/EC establishing a common framework for the marketing of products. It
also intends to align Directive 97/23/EC to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December
2008 on classification, labelling and packaging of substances and mixtures[1].

a)         Alignment to Decision No
768/2008/EC:

Union (EU) harmonisation legislation
ensuring the free movement of products has contributed considerably to the
completion and operation of the Single Market. It is based on a high level of
protection and provides economic operators with the means to demonstrate
conformity, thus ensuring free movement through trust in the products.

Directive 97/23/EC is an example of that
Union harmonisation legislation, ensuring the free movement of pressure
equipment. It sets out essential safety requirements that pressure equipment
and assemblies must comply with in order to be made available on the EU market.
Manufacturers must demonstrate that pressure equipment has been designed and
manufactured in compliance with the essential safety requirements and affix the
CE marking.

Experience with the implementation of Union
harmonisation legislation has shown – on a cross-sector scale - certain
weaknesses and inconsistencies in the implementation and enforcement of this
legislation, leading to:

– 
the presence of non-compliant or dangerous
products on the market and consequently a certain lack of trust in CE marking;

– 
competitive disadvantages for economic operators
complying with the legislation as opposed to those circumventing the rules;

– 
unequal treatment in the case of non-compliant
products and distortion of competition amongst economic operators due to
different enforcement practices;

– 
differing practices in the designation of
conformity assessment bodies by national authorities;

– 
problems with the quality of certain notified
bodies.

Furthermore the regulatory environment has
become more and more complex, as frequently several pieces of legislation apply
simultaneously to one and the same product. Inconsistencies in these pieces of
legislation make it increasingly difficult for economic operators and
authorities to correctly interpret and apply that legislation.

To remedy these horizontal shortcomings in
Union harmonisation legislation observed across several industrial sectors, the
‘New Legislative Framework’ was adopted in 2008 as part of the goods package.
Its objective is to strengthen and complete the
existing rules and to improve practical aspects of their application and
enforcement. The New Legislative Framework (NLF) consists of two complementary
instruments, Regulation (EC) No 765/2008 on accreditation and market
surveillance and Decision No 768/2008/EC establishing a common framework for
the marketing of products (hereinafter NLF Decision).

The NLF Regulation has introduced rules on
accreditation (a tool for the evaluation of competence of conformity assessment
bodies) and requirements for the organisation and performance of market
surveillance and controls of products from third countries. Since 1 January
2010 these rules apply directly in all Member States.

The NLF Decision sets out a common
framework for EU product harmonisation legislation. This framework consists of
the provisions which are commonly used in EU product legislation (e.g. definitions,
obligations of economic operators, notified bodies, safeguard mechanisms, etc.).
These common provisions have been reinforced to ensure that the directives can
be applied and enforced more effectively in practice. New elements, such as
obligations on importers, have been introduced, which are crucial for improving
the safety of products on the market.

The provisions of the NLF Decision and
those of the NLF Regulation are complementary and closely interlinked. The NLF
Decision contains the corresponding obligations for economic operators and
notified bodies allowing market surveillance authorities and authorities
responsible for notified bodies to properly perform the tasks imposed on them
by the NLF Regulation and to ensure an effective and consistent enforcement of
EU product legislation.

However, unlike the NLF Regulation, the
provisions of the NLF Decision are not directly applicable. To ensure that all
economic sectors subject to Union harmonisation legislation benefit from the
improvements of the NLF, the provisions of the NLF Decision need to be
integrated into the existing product legislation.

The Commission has already proposed the
alignment of nine other Directives to the NLF Decision within an NLF
implementation package adopted on 21 November 2011[2].

In view of ensuring consistency across
Union harmonisation legislation for industrial products, it is necessary to
align Directive 97/23/EC to the provisions of the NLF Decision.

The proposal also takes into account the proposal
of the Commission of 13 February 2013 for a Regulation on market surveillance
of products[3].

b)         Alignment to Regulation (EC) No
1272/2008:

Regulation (EC) No 1272/2008 (hereinafter
CLP Regulation), implements within the Union the Globally Harmonised System of
Classification and Labelling of Chemicals (GHS) that has been adopted at the
international level, within the structure of the United Nations.

Directive 97/23/EC provides, in Article 9, for
a classification of pressure equipment in categories, according to the ascending
level of risk due to pressure. While the
classification of pressure equipment under the Directive is mainly based on the
total energetic content (pressure and volume of the pressure equipment), it is
also influenced by the classification (dangerous or not) of the fluid it
contains.

The classification of
pressure equipment into categories is directly related to the conformity
assessment procedure applied in order to verify the conformity of the pressure equipment
to the essential requirements of Directive 97/23/EC. In particular, the
conformity assessment procedure to be applied is determined by the category, as
defined in Article 9, in which the equipment is classified.

The classification of
the fluids contained in the pressure equipment for the purposes of the
classification of the pressure equipment in view of its conformity assessment, is
based on Council Directive 67/548/EEC of 27 June 1967
on the approximation of the laws, regulations and administrative provisions
relating to the classification, packaging and labelling of dangerous substances[4].

According to Article 9 of Directive
97/23/EC, the ‘fluids’ are divided into two groups. Group 1 comprises the
following ‘dangerous fluids’[5],
as classified on the basis of their intrinsic properties and the degree and
specific nature of the hazards involved in Directive 67/548/EEC: explosive,
extremely flammable, highly flammable, flammable, very toxic, toxic and oxidising.
Group 2 comprises all other fluids not referred to in Directive 97/23/EC as
‘dangerous’.

To take account of the pressure hazards
associated with dangerous fluids, the conformity assessment requirements of
Directive 97/23/EC are more stringent for pressure equipment containing Group 1
fluids than for pressure equipment containing Group 2 fluids.

According to Regulation (EC) No 1272/2008, Directive
67/548/EEC will be repealed on 1 June 2015 and replaced by the Regulation. That
Regulation introduces new hazard classes and categories only partially
corresponding to those used under the current provisions.

The fluid classification criteria of Directive
97/23/EC must therefore be aligned to the classification criteria of Regulation
(EC) No 1272/2008 until 1 June 2015, while maintaining the existing levels of
protection of the Directive.

The alignment of Directive 97/23/EC to the
CLP Regulation requires therefore redefining what constitutes a ‘dangerous
fluid’ in the terms of the new classification introduced by the Regulation.

The need to align the fluid classification
criteria of Directive 97/23/EC to the CLP Regulation is therefore a direct consequence
of implementing the CLP Regulation in the Union, which requires all downstream
legislation to be aligned to the CLP Regulation at the latest by the date on
which Directive 67/548/EEC will be repealed (1 June 2015).

Although the two classification systems provided
by the CLP Regulation and Directive 67/548/EEC are similar, there is no perfect
match. Some substances are classified differently under the CLP Regulation than
under Directive 67/548/EEC due to changes in the classification criteria or
cut-off values. A change in the classification of the fluid (substance or preparation)
contained in the pressure equipment may therefore result in a change of the
classification of the pressure equipment itself (categories of pressure
equipment).

Directive 97/23/EC provides for four
categories of pressure equipment, according to the ascending pressure related
hazard. For each category of pressure equipment, the Directive provides for a
set of conformity assessment procedures. Pressure equipment must be subject to
one of the conformity assessment procedures which may be chosen by the
manufacturer among those laid down for the category in which the pressure equipment
is classified. The manufacturer may also choose to apply one of the procedures
which apply to a higher category, if available.

The change in category under Directive
97/23/EC is having an impact only on the conformity assessment procedure and
not on the design or manufacturing of the pressure equipment itself. If pressure
equipment is classified in a higher category due to the fluid it contains, it
may result in a more demanding and more expensive conformity assessment
procedure.

As the current
provision[6]
related to the classification of pressure equipment based also on the characteristics
of the fluid it contains is considered satisfactory, Directive 97/23/EC should
be aligned to the CLP Regulation while maintaining the current scope in
relation to the hazards due to the fluids. The new classification of the fluids
should therefore match as close as possible the current classification based on
Directive 67/548/EEC.

The proposed alignment
is therefore a technical alignment primarily designed to minimize the impact of
the changes in the classification system of the fluids introduced by the CLP
Regulation on the classification of the pressure equipment itself.

Consistency with other policies and
objectives of the Union

This initiative is in
line with the Single Market Act[7],
which stressed the need to restore consumer confidence in the quality of
products on the market and the importance of reinforcing market surveillance.

Furthermore it supports
the Commission’s policy on Better Regulation and simplification of the
regulatory environment.

2.           CONSULTATION OF THE INTERESTED PARTIES
AND IMPACT ASSESSMENT

Consultation of interested parties

a)         The alignment of Directive
97/23/EC to the NLF Decision has been discussed with national experts
responsible for the implementation of the Directive, the conformity assessment
bodies’ forum, the administrative cooperation group on market surveillance as
well as in bilateral contacts with industry associations.

From June to October 2010 a public
consultation was organised that comprised all the sectors involved in this
initiative. It consisted of four targeted questionnaires for economic
operators, authorities, conformity assessment bodies and users and the
Commission services received 300 replies. The results are published at:

http://ec.europa.eu/enterprise/policies/single-market-goods/internal-market-for-products/new-legislative-framework/index_en.htm

In addition to the general consultation a
specific SME consultation was carried out. 603 SMEs were consulted through the
Enterprise Europe Network in May/June 2010. The results are available at http://ec.europa.eu/enterprise/policies/single-market-goods/files/new-legislative-framework/smes_statistics_en.pdf

The consultation process revealed
widespread support for the initiative. There is unanimity on the need to improve
market surveillance and the system for assessing and monitoring conformity assessment
bodies. Authorities fully support the exercise because it will strengthen the
existing system and improve cooperation at EU level. Industry expects a more
level playing field resulting from more effective actions against products that
do not comply with the legislation, as well as a simplification effect from the
alignment of legislation. Certain concerns were expressed on some obligations
which are, however, indispensable for increasing the efficiency of market
surveillance. These measures will not entail significant costs for industry and
the benefits resulting from improved market surveillance should by far outweigh
the costs.

b)         The
alignment of Directive 97/23/EC to the CLP Regulation has been discussed with
national experts responsible for the implementation of the Directive, the conformity
assessment bodies’ forum, the administrative cooperation group as well as in
bilateral contacts with industry associations.

An impact assessment study on the alignment
of Directive 97/23/EC to the CLP Regulation was conducted in 2012.

In the context of this study, a survey was
organised amongst key stakeholders. The Commission organised a workshop on 7
November 2012 in order to collect further information and to allow direct
interaction with stakeholders. The workshop was attended by representatives of
national authorities, user and manufacturer associations, conformity assessment
bodies, standardisers and experts in the field of the CLP Regulation.

Collection and use of expertise - Impact
assessment

a)         Impact assessment concerning
the alignment to the NLF Decision

In addition to the general impact
assessment for the New Legislative Framework, an impact assessment was conducted
for the NLF implementation package adopted in November 2011. That impact
assessment covered also the alignment of Directive 97/23/EC to the NLF Decision
and was largely built on the general impact assessment carried out for
the New Legislative Framework. In addition to the expertise collected and
analysed in that context, further consultation of the sector-specific experts
and interest groups, as well as horizontal experts active in the area of
technical harmonisation, conformity assessment, accreditation and market
surveillance, has taken place.

Based on the information collected, the
Commission carried out an impact assessment which examined and compared three
options.

Option 1 - No changes to the current
situation

This option proposes no changes to the current
directive and relies exclusively on certain improvements that can be expected
from the NLF Regulation.

Option 2 – Alignment to the NLF Decision
by non-legislative measures

Option 2 considers the possibility of
encouraging a voluntary alignment to the provisions set out in the NLF Decision
by, e.g., presenting them as best practices in guidance documents.

Option 3 – Alignment to the NLF Decision
by legislative measures

This option consists in integrating the
provisions of the NLF Decision into Directive 97/23/EC.

Option 3 was
found to be the preferred option because:

– 
it will improve the competitiveness of companies
and conformity assessment bodies taking their obligations seriously;

– 
it will improve the functioning of the internal
market by ensuring equal treatment of all economic operators, notably importers
and distributors, as well as conformity assessment bodies;

– 
it does not entail significant costs for
economic operators and conformity assessment bodies; for those who are already
acting responsibly, no extra costs or only negligible costs are expected;

– 
it is considered more effective than option 2:
due to the lack of enforceability of option 2 it is questionable that the
positive impacts would materialise under that option;

– 
options 1 and 2 do not provide answers to the
problem of inconsistencies in the regulatory framework and therefore have no
positive impact on the simplification of the regulatory environment.

As outlined above in option 3, the
alignment of Directive 97/23/EC to the NLF Decision will lead to a better
implementation of the Directive.

The proposal includes:

· 
Measures to address the problem of
non-compliance by clarifying the obligations of economic operators and
requiring enhanced traceability requirements.

· 
Measures intended to ensure the quality of work
done by conformity assessment bodies by reinforcing the notification
requirements, revised notification process, specifying requirements for
notifying authorities and more stringent information obligations.

· 
Measures intended to ensure greater consistency
amongst Directives by aligning commonly used definitions and terminology and
aligning the conformity assessment procedures.

The impact of these measures will lead to
strengthening the competitiveness of European enterprises as a result of guaranteeing
a level playing field for the economic operators.

b)         Impact assessment concerning
the alignment to the CLP Regulation

The alignment of Directive 97/23/EC to the
CLP Regulation is a direct consequence of implementing the CLP Regulation in the
Union.

In particular, the classification of hazardous
substances and mixtures is regulated at European level by the CLP Regulation
which transposes the international Global Harmonised System (GHS) in the EU.

Therefore, the objective of the alignment
of Directive 97/23/EC to the CLP Regulation is to ensure legal coherence. Such
an alignment requires only the modification of Article 9(2) of Directive
97/23/EC.

A non-alignment to the CLP Regulation would
lead to legal uncertainty as from 1 June 2015, when Directive 67/548/EEC will
be repealed, because, as from this date, there would be no legal basis for the classification
of pressure equipment based on the fluid it contains.

The evaluation study of Directive 97/23/EC
completed in November 2012, concluded that there is no urgent need for a full
revision of Directive 97/23/EC. Better implementation of the Directive can be
achieved by introducing the NLF provisions and by complementary measures such
as improving the market surveillance. Additional studies should be conducted
before preparing a full revision of the Directive, analysing e.g. issues
related to the scope, technical provisions related to the essential safety
requirements, etc... It also confirmed that the current classification mechanism
of the pressure equipment provided for by the Directive and based also on the
classification of the fluid is satisfactory.

The proposed alignment options are the
result of a technical mapping of the current hazard classes of dangerous
substances and preparations provided for by Directive 97/23/EC and based on
Directive 67/548/EEC to the hazard classes for the classification of substances
and mixtures classified as hazardous in accordance with the CLP Regulation. This
technical mapping results to minimal changes to the existing classification
system of pressure equipment provided for by Directive 97/23/EC.

Similar to the current provisions of
Directive 97/23/EC, the proposal should therefore address the physical and
health hazards due to the fluids contained in the pressure equipment, as far as
relevant for the classification of pressure equipment in view of its conformity
assessment.

For most pressure equipment there will be
no change of the classification of the equipment due to the alignment to the
CLP Regulation.

The best possible mapping between Directive
67/548/EEC and the CLP Regulation should be envisaged reducing the impact of
this change to the minimum. The technical detail of the alignment and the
options chosen on how to modify Article 9(2) of Directive 97/23/EC could lead
to increasing or reducing the number of substances or mixtures included in Group
1 of Directive 97/23/EC (the group which imposes more demanding requirements with
regard to the conformity assessment procedures).

The impact of the various options has been
analysed in an impact assessment study on the alignment of Directive 97/23/EC to
the CLP Regulation, finalised in February 2013.

It results from the analysis that whilst
there will be changes in the terminology used to identify the hazards, only a
small number of fluids will be classified in a different group under Directive
97/23/EC possibly leading to a different classification of the pressure
equipment itself.

A possible change in the classification of
the fluids under Directive 97/23/EC does not always necessarily result in a different
classification of the pressure equipment itself since such classification of
the equipment depends not only on the nature of the fluid but also on the total
energetic content (based on the pressure and the volume of the equipment).

In particular, the transition from Directive
67/548/EEC to the CLP Regulation for physical hazards is reasonably smooth as
there is a good matching between that Directive and the new classification
under the CLP Regulation. Only for a few substances the classification will
change because the CLP Regulation introduces new cut-off values for the
flammability criteria.

The transition from Directive 67/548/EEC to
the CLP Regulation for the health hazards is more complex as the boundaries of
some categories do not always align with those of Directive 67/548/EEC, as the
CLP Regulation introduces also new hazard classes and categories.

In particular, the hazard classes and
categories related to acute toxicity have been analysed more in detail with
regard to their potential safety and economic impact.

With regard to the hazard classes for acute
toxicity, the findings can be summarized as follows:

- the inclusion of the fluids that are
classified under the hazard classes acute oral toxicity category 1 and 2 in
Group 1 under Directive 97/23/EC will lead to a decrease in the number of fluids
(in the meaning of substances or preparations) in Group 1. This option is
supported by the fact that the oral take-up of substances or mixtures due to
failure of pressure equipment cannot be excluded but the risk is very limited.
This option would therefore not cause an unacceptable safety risk. However, the
inclusion of acute oral toxicity category 3 would lead to a substantial
increase in the number of fluids in Group 1, possibly resulting in a higher
category of the equipment which may lead to an increase of the costs of the
conformity assessment, without a substantial gain in the level of safety.

- the inclusion of the fluids that are
classified under the hazard classes acute dermal toxicity category 1 and 2 will
lead to a small decrease in the number of fluids (in the meaning of substances
or preparations) in Group 1 under Directive 97/23/EC. This option is supported
by the fact that dermal contact with substances or mixtures due to failure of
pressure equipment cannot be excluded but the risk is rather limited and would
not cause an unacceptable safety risk. However, the inclusion of acute dermal
toxicity category 3 would lead to a relatively small increase in the number of fluids
in Group 1, without a substantial gain in the level of safety.

- the inclusion of the fluids that are
classified under the hazard classes acute toxicity inhalation category 3 in
addition to category 1 and 2 will lead to an increase of fluids (in the meaning
of substances or preparations) in Group 1 under Directive 97/23/EC which is
justified given the risk that might exist due to small leakages of fluids in
the pressure equipment.

In summary, for most of the fluids used in
pressure equipment, there will be no change in the classification of the
equipment due to the alignment to the CLP Regulation. For a limited number of
fluids, used in a limited number of applications, the alignment to the CLP
Regulation may lead to a different classification of the equipment and may
influence the cost for the conformity assessment process.

The impact assessment study concluded that the
impact of the proposed alignment would be limited and in particular that the
overall economic impact will be low considering that the proposed alignment
options are aiming at the best possible mapping between the current
classification (based on Directive 67/548/EEC) and the future one (based on the
CLP Regulation).

Based on the number of substances that
would be subject to a different classification and the proportion of
manufacturers that would be affected, the impact assessment study estimates the
overall costs of aligning Directive 97/23/EC to the CLP Regulation to be of the
order of 8,5 million euros per year. The cost is due to the changes in the
alignment for the health hazard classes.

However, looking at the current compliance
costs, and according to the impact assessment study, the total average cost of
the conformity assessment for the pressure equipment covered by Directive
97/23/EC is estimated at 236,3 million euros per year.

Therefore, the incremental cost due to the alignment
of Directive 97/23/EC to the CLP Regulation is low compared to the total cost
for conformity assessment. However, the implementation of the CLP Regulation in
the Union is mandatory and the cost cannot be avoided.

The impact assessment study is available
at: http://ec.europa.eu/enterprise/sectors/pressure-and-gas/documents/ped/index_en.htm

On the basis of the above, the Commission concluded
that:

a)         There is no alternative course
of action because all downstream legislation which is using classification of
chemical substances has to be aligned to the CLP Regulation, which is the European
Union initiative transposing the international Global Harmonised System (GHS)
in the EU. The current legal basis for the classification of substances and
preparations, referred to in Article 9(2.1) of Directive 97/23/EC, namely
Directive 67/548/EEC, will be repealed on 1 June 2015. By that time, Directive
97/23/EC should be modified and refer to the CLP Regulation for the purpose of the
classification of pressure equipment within its scope. The proposed alignment
is therefore a technical alignment which is primarily designed to minimize the
impact of the changes in the classification system of the pressure equipment
itself and to guarantee legal certainty as from 1 June 2015.

b)         The impact assessment study did
not identify significant economic or health related impacts.

3.           Main elements of the proposal

3.1. Horizontal definitions

The proposal
introduces harmonised definitions of terms which are commonly used throughout
Union harmonisation legislation and should therefore be given a consistent
meaning throughout that legislation.

3.2. Obligations of economic operators
and traceability requirements

The proposal clarifies the obligations of
manufacturers and authorised representatives and introduces obligations for
importers and distributors. Importers must verify that the manufacturer has
carried out the applicable conformity assessment procedure and has drawn up a
technical documentation. They must also make sure with the manufacturer that
this technical documentation can be made available to authorities upon request.
Furthermore importers must verify that pressure equipment is correctly marked
and accompanied by the instructions and safety information. They must keep a
copy of the Declaration of conformity and indicate their name and address on
the product, or where this is not possible on the packaging or the accompanying
documentation. Distributors must verify that pressure equipment bears the CE
marking, the name of the manufacturer and of the importer, if relevant, and
that it is accompanied by the required documentation and instructions.

Importers and distributors must cooperate
with market surveillance authorities and take appropriate actions when they
have supplied non-compliant pressure equipment.

Enhanced traceability obligations are introduced for all economic operators. Pressure equipment has
to bear the manufacturer’s name and address and a number allowing to identify
and link the pressure equipment to its technical documentation. When pressure
equipment is imported the importer’s name and address must also be on the
pressure equipment. Furthermore every economic operator must be able to
identify towards authorities the economic operator who has supplied him with
pressure equipment or to whom he has supplied pressure equipment.

3.3. Harmonised standards

Compliance with harmonised standards
provides for a presumption of conformity with the essential requirements. Regulation
(EU) No 1025/2012 of the European Parliament and of the Council of 25 October
2012 on European Standardisation, amending Council Directives 89/686/EEC and
93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament
and of the Council and repealing Council Decision 87/95/EEC and Decision No
1673/2006/EC of the European Parliament and of the Council[8] sets out a horizontal legal
framework for European standardisation. The Regulation contains inter alia
provisions on standardisation requests from the Commission to the European
Standardisation Organisation, on the procedure for objections to harmonised
standards and on stakeholder participation in the standardisation process. Consequently,
it repealed Article 6 of Directive 97/23/EC covering the same aspects. The
provision conferring presumption of conformity to harmonised standards has been
modified to clarify the extent of the presumption of conformity when standards
only partially cover the essential requirements.

3.4. Conformity assessment and CE marking

Directive 97/23/EC has selected the
appropriate conformity assessment procedures which manufacturers have to apply
in order to demonstrate that their pressure equipment complies with the
essential safety requirements. The proposal aligns these procedures to their
updated versions set out in the NLF Decision.

General principles of the CE marking are
set out in Article 30 of Regulation (EC) No 765/2008, while the detailed
provisions on the affixing of the CE marking to pressure equipment have been
inserted in this proposal.

3.5. Conformity assessment bodies

The proposal reinforces the notification
criteria for conformity assessment bodies, namely notified bodies but also
recognised third-party organisations and user inspectorates. It clarifies that
subsidiaries or subcontractors must also comply with the notification
requirements. Specific requirements for notifying authorities are introduced
and the procedure for notification of notified bodies and user inspectorates
and for designation of recognised third-party organisations is revised. The
competence of conformity assessment bodies must be demonstrated by an
accreditation certificate. Where accreditation has not been used to evaluate
the competence of a conformity assessment body, the notification must comprise
the documentation demonstrating how the competence of that body has been
evaluated. Member States will have the possibility to object to a notification.

3.6. Market surveillance and the
safeguard clause procedure

On 13 February 2013, the Commission adopted
a proposal for a Regulation on market surveillance of products, which intends
to set out a single legal instrument on the market surveillance activities in
the field of non-food goods, consumer or non-consumer products and products
covered or not by Union harmonisation legislation. The proposal merges the
rules on market surveillance of Directive 2001/95/EC on general product safety[9], Regulation (EC) No 765/2008
and sector- specific harmonisation legislation in order to increase the
effectiveness of market surveillance activities within the Union. The proposed
Regulation covers also the reference provisions on market surveillance and
safeguard clauses contained in the NLF Decision. Therefore, provisions in
existing Union harmonisation legislation that relate to market surveillance and
safeguard clauses should be removed from that harmonisation legislation.

The overarching objective of the proposed
Regulation is to simplify the Union market surveillance framework fundamentally
so that it works better for its main users: market surveillance authorities and
economic operators. This will result in a better implementation of the market
surveillance rules across Member States, providing better protection for
consumers and other users, reduced administrative burdens and enhanced
information and work-sharing between market surveillance authorities.

In this framework, the proposed Regulation
will lead to a better implementation of Directive 97/23/EC, which covers
consumer and non-consumer products, and to an improved competitiveness
framework in the internal market.

On this basis, the proposal does not
include provisions on market surveillance and safeguard clause procedures, but in
order to ensure legal clarity, it makes a reference to the proposed Regulation
on market surveillance of products.

3.7. Classification of pressure
equipment

The proposal modifies Article 9(2) of
Directive 97/23/EC so as to align, for purposes related to the conformity
assessment of the pressure equipment, the current classification of fluids
contained in the equipment and which is based on the classification of dangerous
substances and preparations provided for by Directive 67/548/EEC, to the new
classification of hazardous substances and mixtures provided for by the CLP Regulation.

3.8. Comitology and delegated acts

The provisions on the operation of the
Committee on Pressure Equipment have been adapted to the new rules on delegated
acts laid down in Article 290 of the Treaty on the Functioning of the EU and to
the new provisions on implementing acts laid down in Regulation (EU) No
182/2011 of the European Parliament and of the Council of 16 February 2011
laying down the rules and general principles concerning mechanisms for control
by the Member States of the Commission's exercise of implementing powers[10].

4. legal elements of the proposal

Legal basis

The proposal is based on Article 114 of the
Treaty on the Functioning of the European Union.

Subsidiarity principle

The internal market is a competence that is
shared between the Union and the Member States. The subsidiarity principle
arises in particular with regard to the newly added provisions aiming at the
improvement of effective enforcement of Directive 97/23/EC, namely, the
importer and distributor obligations, the traceability provisions, the
provisions on the assessment and notification of conformity assessment bodies,
and the enhanced cooperation obligations in the context of the revised market
surveillance and safeguard procedures.

Experience with the enforcement of the
legislation has shown that measures taken at national level have led to
divergent approaches and to a different treatment of economic operators inside
the EU, which undermines the objective of this directive. If actions are taken
at national level to address the problems, this risks creating obstacles to the
free movement of goods. Furthermore action at national level is limited to the
territorial competence of a Member State. In view of the increasing
internationalisation of trade, the number of cross-border cases is constantly
rising. Coordinated action at EU level can much better achieve the objectives
set, and will in particular render market surveillance more effective. Hence it
is more appropriate to take action at EU level.

As regards the problem of inconsistencies
throughout the directives, this is a problem which can only be solved by the EU
legislator.

In accordance with the
principle of proportionality, the modifications to be proposed will not go
beyond what is necessary to achieve the objectives set.

Proportionality

In accordance with the principle of
proportionality, the proposed modifications do not go beyond what is necessary
to achieve the objectives set.

The new or modified obligations do not
impose unnecessary burdens and costs on industry - especially on small and
medium sized enterprises - or administrations. Where modifications have been identified
to have negative impacts, the analysis of the impacts of the option serves to
provide the most proportionate response to the problems identified. A number of
modifications concern the improvement of clarity of the existing Directive
without introducing new requirements that entail added cost.

Legislative technique used

The alignment to the NLF Decision and to
the CLP Regulation requires a number of substantive amendments to the
provisions of Directive 97/23/EC. To ensure the readability of the amended text
the technique of recasting has been chosen in line with the Inter-institutional
Agreement of 28 November 2001 on a more structured use of the recasting
technique for legal acts[11].

The changes made to the provisions of
Directive 97/23/EC concern: the definitions, the obligations of economic
operators, the presumption of conformity provided by harmonised standards, the
declaration of conformity, CE marking, conformity assessment bodies, the
safeguard clause procedure, the conformity assessment procedures and the
classification of the fluids.

The proposal does not change the scope of
Directive 97/23/EC and the essential safety requirements.

5.           BUDGETARY IMPLICATION

This proposal does not have any
implications for the EU budget.

6.           ADDITIONAL INFORMATION

Repeal of existing legislation

The adoption of the proposal will lead to
repeal of Directive 97/23/EC as from 1 June 2015.

In particular, in order to ensure the
simultaneous and coherent implementation of the alignment of Directive 97/23/EC
to Decision 768/2008/EC and to Regulation (EC) No 1272/2008, the proposal
provides that the new Directive will apply as from 1 June 2015.

European Economic Area

The proposal concerns the EEA and should
therefore be extended to the European Economic Area.

ê 97/23/EC
(adapted)

2013/0221 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on the approximation Ö harmonisation Õ of the laws of
the Member States concerning
Ö relating
to making available on the market of Õ pressure
equipment

(Recast)

(Text with EEA relevance)

THE
EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community Ö on
Functioning of the European Union Õ and in
particular Article 100a
Ö 114 Õ thereof,

Having regard to the proposals from the European
Commission,

After transmission of the draft legislative
act to the national Parliaments,

Having regard to the Opinion of the
European Economic and Social Committee[12],

Acting in accordance with the ordinary
legislative procedure,

Whereas:

ò new

(1)       Directive
97/23/EC of the European Parliament and of the Council of 29 May 1997 on the
approximation of the laws of the Member States concerning pressure equipment[13] has been substantially amended
several times. Since further amendments are to be made, it should be recast in
the interests of clarity.

(2)       Regulation
(EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008
setting out the requirements for accreditation and market surveillance relating
to the marketing of products and repealing Regulation (EEC) No 339/93[14] lays down rules on the
accreditation of conformity assessment bodies [provides a framework for the
market surveillance of products and for controls on products from third
countries,] and lays down the general principles of the CE marking.

(3)       Decision
No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on
a common framework for the marketing of products and repealing Council Decision
93/465/EEC[15]
lays down a common framework of general principles and reference provisions
intended to apply across the legislation harmonising the conditions for the
marketing of products in order to provide a coherent basis for revision or
recasts of that legislation. Directive 97/23/EC should therefore be adapted to
that Decision.

ê 97/23/EC
recital 1 (adapted)

Whereas the
internal market is an area without internal frontiers in which the free
movement of goods, persons, services and capital is ensured;

ê 97/23/EC
recital 2

Whereas there
are differences in the content and scope of the laws, regulations and
administrative provisions in force in the Member States with regard to the
safety and protection of health of persons and, where appropriate, domestic
animals or property, where pressure
equipment not covered by present Community legislation is concerned; whereas
the certification and inspection procedures for such equipment differ from one
Member State to another; whereas such disparities may well constitute barriers
to trade within the Community;

ê 97/23/EC
recital 3

Whereas the
harmonization of national legislation is the only means of removing these
barriers to free trade; whereas this objective cannot be achieved
satisfactorily by the individual Member States; whereas this Directive only
lays down indispensable requirements for the free circulation of the equipment
to which it is applicable;

ê 97/23/EC
recital 4 (adapted)

(4)       Whereas equipment subject to a pressure of not
more than 0,5 bar does not pose a significant hazard due to pressure;
whereas there should not therefore be any obstacle to its free movement within
the Community; This Directive applies Ö should apply Õ to
equipment subject to a maximum allowable pressure PS exceeding Ö greater
than Õ 0,5 bar. Ö Equipment
subject to a pressure of not more than 0,5 bar does not pose a significant risk
due to pressure. Therefore, there should not be any obstacle to its free
movement within the Union. Õ

ê 97/23/EC
recital 5 (adapted)

(5)       This Directive relates also
Ö should
also apply Õ to assemblies
composed of several pieces of pressure equipment assembled to constitute an
integrated and functional whole. These Ö Those Õ assemblies may
range from simple assemblies such as pressure cookers to complex assemblies
such as water tube boilers. If the manufacturer of an assembly intends it to be placed
Ö place it Õ on the market
and put Ö it Õ into service
as an assembly - and not in the form of its constituent non-assembled elements
- that assembly must
conform to Ö should comply
with Õ this
Directive. On the other hand
Ö However Õ, this
Directive does not
cover Ö should
not apply to Õ the
assembly of pressure equipment on the site and under the responsibility of the
user, as in the case of industrial installations.

ê 97/23/EC
recital 6 (adapted)

(6)       This Directive harmonises Ö should
harmonise Õ national
provisions on hazards
Ö risks Õ due to
pressure. The other hazards
Ö risks Õ which this
equipment may present accordingly may fall within the scope of other
Directives dealing with such hazards Ö those risks Õ.

(7)       However, Ö some Õ pressure
equipment may be
included among products Ö is Õ covered by
other Directives based on Article 100a Ö 114 Õ of the Treaty.
The provisions laid down in some of those Directives deal Ö also Õ with the hazard Ö risk Õ due to pressure.
Those provisions
Ö Directives Õ are considered
adequate to provide appropriate protection where the hazard Ö risk Õ due to
pressure associated with such equipment remains small. Therefore, there are grounds for
excluding such equipment Ö should be
excluded Õ from the scope
of this Directive.

ê 97/23/EC
recital 7 (adapted)

ð new

(8)       For Ö some Õ pressure
equipment covered by international Conventions, Ö agreements
for its international transport, national Õ transport and
pressure hazards
Ö risks Õ are due to be
dealt with as soon
as possible by forthcoming Community Ö Union Õ Directives
based on such Conventions
Ö agreements Õ or by supplements to existing Directives
ð by extending the application of
those agreements to national transport, in order to ensure the free movement of
such dangerous goods whilst enhancing transport safety ï. Such equipment ð which is covered by Directive
2008/68/EC of the European Parliament and of the Council of 29 September 2008 on
the inland transport of dangerous goods[16]
and by Directive 2010/35/EU of the European Parliament and of the Council of 16
June 2010 on transportable pressure equipment and repealing Council Directives
76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC[17] ï is
accordingly
Ö should be Õ excluded from
the scope of this Directive.

ê 97/23/EC
recital 8 (adapted)

(9)       Certain types of pressure
equipment, although subject to a maximum allowable pressure PS higher Ö greater Õ than 0,5 bar,
do not present any significant hazard Ö risk Õ due to
pressure, and therefore the freedom of Ö free Õ movement of
such equipment in the Community Ö Union Õ should not be
hindered if it has been legally manufactured or placed on the market in a
Member Stat. It is not necessary in order to ensure free movement of such
equipment to include it in the scope of this Directive. Consequently it is Ö should be Õ expressly
excluded from its scope.

ê 97/23/EC
recital 9 (adapted)

(10)     Other pressure equipment
subject to a maximum allowable pressure higher Ö greater Õ than 0,5 bar
and presenting a significant hazard Ö risk Õ due to
pressure, but in respect of which free movement and an appropriate level of
safety are guaranteed, is Ö should
be Õ excluded from
the scope of this Directive. Such exclusions should, however, be regularly
reviewed in order to ascertain whether it is necessary to take action at Union
level.

ê 97/23/EC
recital 10

Whereas
regulations to remove technical barriers to trade must follow the new approach
provided for in the Council Resolution of 7 May 1985 on a new approach to
technical harmonization and standards[18], which requires a definition of the essential
requirements regarding safety and other requirements of society without
reducing existing, justified levels of protection within the Member States;
whereas that Resolution provides that a very large number of products be covered by a single Directive in order to
avoid frequent amendments and the proliferation of Directives;

ê 97/23/EC
recital 11

Whereas the existing Community Directives on the approximation
of the laws of the Member States relating to pressure equipment have made
positive steps towards removing barriers to trade in this area; whereas those Directives cover that sector only to a minor
extent; whereas Council Directive 87/404/EEC of 25 June 1987 on
the harmonization of the laws of the Member States relating to simple
pressure vessels[19] is the first case of application of the new
approach to the sector of pressure equipment; whereas the present Directive will not apply to the area
covered by Directive 87/404/EEC; whereas, no later than three years after
the present Directive enters into force, a review will be carried out of the
application of Directive 87/404/EEC in order to ascertain the need for the
integration thereof into the present Directive;

ê 97/23/EC
recital 12

Whereas the
framework Directive, Council Directive 76/767/EEC of 27 July 1976 on the
approximation of the laws of the Member States relating to common provisions
for pressure vessels and methods for inspecting them[20] is optional; whereas it provides for a procedure
for the bilateral recognition of testing and certification of pressure
equipment which did not operate satisfactorily and which therefore must be
replaced by effective Community measures;

ê 97/23/EC
recital 13 (adapted)

(11)     The scope of this Directive must Ö should Õ be based
on a general definition of the term «pressure equipment» so as to allow for the
technical development of products.

ê 97/23/EC
recital 14 (adapted)

(12)     Compliance with the essential
safety requirements is necessary in order to ensure the safety of pressure
equipment. Those requirements have been Ö should be Õ subdivided
into general and specific requirements which must Ö that need
to Õ be met by
pressure equipment. In particular the specific requirements are intended to
Ö should Õ take
account of particular types of pressure equipment. Certain types of pressure
equipment in categories III and IV must Ö should Õ be subject to
a final assessment comprising final inspection and proof tests.

ê 97/23/EC
recital 15 (adapted)

(13)     Member States should be in
a position to allow the showing at trade fairs of pressure equipment which is
not yet in conformity with the requirements of this Directive. During
demonstrations, appropriate safety measures must Ö should Õ be taken in
accordance with the general safety rules of the Member State concerned to
ensure the safety of persons.

ò new

(14)     Directive
97/23/EC provides for a classification of pressure equipment in categories,
according to the ascending level of risk due to pressure. This includes the
classification of the fluid contained in the pressure equipment as dangerous or
not, according to Council Directive 67/548/EEC of 27 June 1967 on the
approximation of the laws, regulations and administrative provisions relating
to the classification, packaging and labelling of dangerous substances[21]. On 1 June 2015 Directive
67/548/EEC is to be repealed and replaced by Regulation (EC) No 1272/2008 of
the European Parliament and of the Council of 16 December 2008 on
classification, labelling and packaging of substances and mixtures[22], which implements in the Union
the Globally Harmonised System of Classification and Labelling of Chemicals
that has been adopted at international level, within the United Nations (UN) structure.
Regulation (EC) No 1272/2008 introduces new hazard classes and categories only
partially corresponding to those provided for by Directive 67/548/EEC.
Directive 97/23/EC should therefore be aligned to Regulation (EC) No 1272/2008 while
maintaining the existing levels of protection of that Directive.

(15)     Economic
operators should be responsible for the compliance of pressure equipment with
the requirements of this Directive, in relation to their respective roles in
the supply chain, so as to ensure a high level of protection of public
interests, such as health and safety and the protection of users, and to
guarantee fair competition on the Union market.

(16)     All
economic operators intervening in the supply and distribution chain should take
appropriate measures to ensure that they only make available on the market
pressure equipment which is in conformity with this Directive. It is necessary
to provide for a clear and proportionate distribution of obligations which
correspond to the role of each economic operator in the supply and distribution
chain.

(17)     The
manufacturer, having detailed knowledge of the design and production process,
is best placed to carry out the complete conformity assessment procedure.
Conformity assessment should therefore remain solely the obligation of the
manufacturer.

(18)     In
order to facilitate the communication between economic operators, national
market surveillance authorities and consumers, Member States should encourage
economic operators to indicate a website address in addition to the postal
address.

(19)     It is necessary to ensure that pressure equipment from third countries entering the Union
market complies with the requirements of this Directive, and in particular that
appropriate conformity assessment procedures have been carried out by
manufacturers with regard to that pressure equipment.
Provision should therefore be made for importers to make sure that the pressure equipment they place on the market complies with the
requirements of this Directive and that they do not place on the market pressure equipment which does not comply with such
requirements or presents a risk. Provision should also be made for importers to
make sure that the conformity assessment procedures have been carried out and that
marking of pressure equipment and documentation drawn up by manufacturers are
available for inspection by the national authorities.

(20)     The distributor makes pressure equipment available on the market after it has been
placed on the market by the manufacturer or the importer and should act with
due care to ensure that its handling of the pressure equipment does not adversely affect the compliance of the
equipment with the requirements of this Directive.

(21)     When
placing pressure equipment on the market, every importer should indicate on the
pressure equipment his name and the postal address at which he can be
contacted. Exceptions should be provided for in cases where the size or nature
of the pressure equipment does not allow it. This includes cases where the
importer would have to open the packaging to put his name and address on the
equipment.

(22)                 Any
economic operator that either places pressure equipment on the market under its
own name or trademark or modifies pressure equipment in such a way that
compliance with the requirements of this Directive may be affected should be
considered to be the manufacturer and should assume the obligations of the manufacturer.

(23)     Distributors and importers, being close to
the market place, should be involved in market surveillance tasks carried out
by the competent national authorities, and should be prepared to participate
actively, providing those authorities with all necessary information relating
to the pressure equipment concerned.

(24)     Ensuring traceability of pressure equipment throughout the whole supply chain helps to make
market surveillance simpler and more efficient. An efficient traceability
system facilitates market surveillance authorities' task of tracing economic
operators who made non-compliant pressure equipment available
on the market.

(25)     When keeping the information required under
this Directive for the identification of economic operators, economic operators
should not be required to update such information in respect of other economic
operators who have either supplied them with a pressure equipment or to whom
they have supplied a pressure equipment.

(26)     This
Directive should be limited to the expression of the essential safety requirements.
In order to facilitate conformity assessment with those requirements it is
necessary to provide for presumption of conformity for pressure equipment which
is in conformity with harmonised standards that are adopted in accordance with
Regulation (EU) No 1025/2012 of
the European Parliament and of the Council of 25 October 2012 on European
Standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and
Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC,
2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the
Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC
of the European Parliament and of the Council[23] for the purpose of expressing detailed
technical specifications of those requirements, especially with regard to the
design, manufacture and testing of pressure equipment.

(27)     Regulation
(EU) No 1025/2012 provides for a procedure for objections to harmonised
standards where those standards do not entirely satisfy requirements of this
Directive.

ê 97/23/EC
recital 16

Whereas in order to ease the task of demonstrating compliance
with the essential requirements,
standards harmonized at
European level are useful, especially with regard to the design, manufacture
and testing of pressure equipment, compliance with which enables a product to
be presumed to meet the said essential requirements; whereas standards harmonized at European level
are drawn up by private bodies and must retain their non-mandatory status;
whereas, for this purpose, the European Committee for Standardization (CEN) and
the European Committee for Electro-technical Standardization (Cenelec) are recognized as
being the bodies that are competent to adopt harmonized standards that follow
the general guidelines for cooperation between the Commission and those two
bodies signed on 13 November 1984;

ê 97/23/EC
recital 17

Whereas, for
the purposes of this Directive, a harmonized standard is a technical
specification (European standard or harmonization document) adopted by one or
other of those bodies, or by both, at the request of the Commission pursuant to
Council Directive 83/189/EEC of 28 March
1983 laying down a procedure for the provision of information in the field of
technical standards and regulations[24] and in accordance with the general guidelines
referred to above; whereas, in relation to standardization, it would be
advisable for the Commission to be assisted by the Committee set up pursuant
to Directive 83/189/EEC; whereas the Committee will, if necessary, consult
technical experts;

ê 97/23/EC
recital 18 (adapted)

ð new

(28)     Manufacturing of pressure
equipment calls for the utilisation of safe materials. In the absence of
harmonised standards,
it
is useful to define the characteristics of the materials
intended for repeated use Ö should be
established. Those characteristics should be Õ . This definition is
established by European approvals for materials, such approvals being issued by
one of the notified bodies specifically designated for that task. The materials
conforming to the European approvals shall be presumed to satisfy
Ö should
benefit from presumption of conformity with Õ the
essential ð safety ï requirements of this Directive.

ê 97/23/EC
recital 19 (adapted)

ð new

(29)     In view of the nature of
the hazards
Ö risks Õ involved in
the use of pressure equipment ð and in order to enable economic
operators to demonstrate and the competent authorities to ensure that pressure
equipment made available on the market conforms to the essential safety
requirements, ï it is necessary to establish
ð provide for conformity
assessment ï procedures for assessing compliance with the
basic requirements of the Directives. These
procedures must
Ö should Õ be devised in
the light of the level of danger which is inherent in the pressure equipment.
Therefore, for each category of pressure equipment there must Ö should Õ be an adequate
procedure or a choice between different procedures of equivalent stringency. whereas the procedures
adopted are as required by Council Decision 93/465/EEC of 22 July 1993
concerning the modules for the various phases of the conformity assessment
procedures and the rules for the affixing and use of the CE conformity marking,
which are intended to be used in the technical harmonization Directives[25]; ð Decision No 768/2008/EC establishes
modules for conformity assessment procedures, which include procedures from the
least to the most stringent, in proportion to the level of risk involved and
the level of safety required. In order to ensure inter-sectoral coherence and
to avoid ad-hoc variants, conformity assessment procedures should be chosen
from among those modules. ï The details added to these Ö those Õ procedures are
justified by the nature of the verification required for pressure equipment.

ê 97/23/EC
recital 20 (adapted)

(30)     Member States should be in
a position to authorize user inspectorates to carry out certain tasks for
conformity assessment in the framework of this Directive. For that purpose this
Directive Ö should Õ sets
out criteria for the authorizsation of user inspectorates by Member
States.

ê 97/23/EC
recital 21 (adapted)

(31)     Under the conditions laid down
by this Directive, certain procedures for conformity
assessment may
require Ö it should
be possible for Õ each item to
be inspected and tested by a notified body or a user inspectorate as part of
the final assessment of the pressure equipment. In other cases provision should
be made to ensure that the final assessment may be monitored by a notified body
by means of unexpected visits.

ò new

(32)     Manufacturers
should draw up an EU declaration of conformity to provide information required
under this Directive on the conformity of the pressure equipment with the
requirements of this Directive and of other relevant Union harmonisation
legislation.

(33)     To
ensure effective access to information for market surveillance purposes, the
information required to identify all applicable Union acts should be available
in a ‘single EU declaration of conformity’.

ê 97/23/EC
recital 22 (adapted)

ð new

(34)     Pressure equipment will Ö should Õ, as a general
rule, bear the CE marking. affixed either by
the manufacturer or by his authorized representative established within the
Community; whereas the CE marking means that the pressure equipment complies
with the provisions of this Directive and those of other applicable Community
directives on CE marking; ð The CE marking, indicating the conformity of pressure equipment, is the visible consequence of a whole process
comprising conformity assessment in a broad sense. General principles governing
the CE marking and its relationship to other markings are set out in Regulation (EC)
No 765/2008. Rules governing the affixing of the CE marking should be laid down
in this Directive. ï

(35)     For pressure equipment defined in this Directive which presents only
a minor pressure hazard
Ö risk Õ and for which
certification procedures are therefore not justified, the CE marking will Ö should Õ not be affixed.

ò new

(36)     The
conformity assessment procedures set out in this Directive require the
intervention of conformity assessment bodies, which are notified by the Member
States to the Commission.

(37)     Experience
has shown that the criteria set out in Directive 97/23/EC that conformity
assessment bodies have to fulfil to be notified to the Commission are not
sufficient to ensure a uniformly high level of performance of these bodies
throughout the Union. It is, however, essential that all conformity assessment
bodies perform their functions to the same level and under conditions of fair
competition. That requires the setting of obligatory requirements for
conformity assessment bodies wishing to be notified in order to provide
conformity assessment services.

(38)     In
order to ensure a consistent level of conformity assessment quality, it is also
necessary to set requirements for notifying authorities and other bodies
involved in the assessment, notification and monitoring of conformity
assessment bodies.

(39)     If
a conformity assessment body demonstrates conformity with the criteria laid
down in harmonised standards, it should be presumed to comply with the
corresponding requirements set out in this Directive.

(40)     The
system set out in this Directive should be complemented by the accreditation
system provided for in Regulation (EC) No 765/2008. Since accreditation is an
essential means of verifying the competence of conformity assessment bodies, it
should also be used for the purposes of notification.

(41)     Transparent
accreditation as provided for in Regulation (EC) No 765/2008, ensuring the
necessary level of confidence in conformity certificates, should be considered
by the national public authorities throughout the Union as the preferred means
of demonstrating the technical competence of conformity assessment bodies.
However, national authorities may consider that they possess the appropriate
means of carrying out that evaluation themselves. In such cases, in order to
ensure the appropriate level of credibility of evaluations carried out by other
national authorities, they should provide the Commission and the other Member
States with the necessary documentary evidence demonstrating the compliance of
the conformity assessment bodies evaluated with the relevant regulatory
requirements.

(42)     Conformity assessment bodies frequently
subcontract parts of their activities linked to the assessment of conformity or
have recourse to a subsidiary. In order to safeguard the level of protection
required for the pressure
equipment to be placed on the
Union market, it is essential that conformity assessment subcontractors and
subsidiaries fulfil the same requirements as notified bodies in relation to the
performance of conformity assessment tasks. Therefore, it is important that the
assessment of the competence and the performance of bodies to be notified and
the monitoring of bodies already notified cover also activities carried out by
subcontractors and subsidiaries.

(43)     It
is necessary to increase the efficiency and transparency of the notification
procedure and, in particular, to adapt it to new technologies so as to enable
online notification.

(44)     Since
conformity assessment bodies may offer their services throughout the Union, it
is appropriate to give the other Member States and the Commission the
opportunity to raise objections concerning a notified body. It is therefore
important to provide for a period during which any doubts or concerns as to the
competence of conformity assessment bodies can be clarified before they start
operating as notified bodies.

(45)     In
the interests of competitiveness, it is crucial that conformity assessment
bodies apply the conformity assessment procedures without creating unnecessary
burdens for economic operators. For the same reason, and to ensure equal
treatment of economic operators, consistency in the technical application of
the conformity assessment procedures needs to be ensured. That can best be
achieved through appropriate coordination and cooperation between conformity
assessment bodies.

(46)     Member
States should take all appropriate measures to ensure that pressure equipment
may be placed on the market only if, when properly stored and used for their
intended purpose, or under conditions of use which can be reasonably foreseen,
they do not endanger the health and safety of persons. Pressure equipment
should be considered as non-compliant with the essential safety requirements
laid down in this Directive only under conditions of use which can be
reasonably foreseen, that is when such use could result from lawful and readily
predictable human behaviour.

ê 97/23/EC
recital 23

Whereas it is
appropriate that the Member States, as provided for by Article 100a of the
Treaty, may take provisional measures to limit or prohibit the placing on the
market, putting into service and use of pressure equipment in cases where it
presents a particular risk to the safety of
persons and, where appropriate, domestic animals or property, provided that the
measures are subject to a Community control procedure;

ò new

(47)     Regulation
(EU) No [.../...] [on market surveillance of products] providing for a single Union
legal instrument relating to market surveillance of products, applies to pressure
equipment.

ê 97/23/EC
recital 24

Whereas the addressees of any decision taken under this
Directive must be aware of the reasons behind that decision and the means of
appeal open to them;

ê 97/23/EC
recital 25

Whereas it is
necessary to lay down a transitional arrangement enabling pressure equipment
manufactured in compliance with the national regulations in force on the date
of entry into force of this Directive to be marketed and put into service;

ê 97/23/EC
recital 26

Whereas the
requirements laid down in the Annexes should be made as clear as possible so as
to allow all users, including small and medium-sized enterprises (SMEs), to
comply with them easily;

ê 97/23/EC
recital 27

Whereas an
agreement on a modus
vivendi
between the European Parliament, the Council and the Commission concerning the
implementing measures for acts adopted in accordance with the procedure laid
down in Article 189b of the Treaty was reached on 20 December 1994[26];

ò new

(48)     In
order to ensure uniform conditions for the implementation of this Directive,
implementing powers should be conferred to the Commission. Those powers should
be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the
Council of 16 February 2011 laying down the rules and general principles
concerning mechanisms for control by the Member States of the Commission's
exercise of implementing powers[27].

(49)     The
advisory procedure should be used for the adoption of implementing acts
requesting the notifying Member State to take the necessary corrective measures
in respect of notified bodies that do not meet or no longer meet the
requirements for their notification.

(50)     The examination procedure should be used
for the adoption of implementing acts with respect to European approvals for
materials presenting shortcomings and whose references were already published
in the Official Journal of the European Union, given that such decisions
could have consequences on the presumption of conformity with the applicable
essential requirements.

(51)     In
order to take into account the technical developments in pressure equipment
technology, the power to adopt acts in accordance with Article 290 of the
Treaty should be delegated to the Commission in respect of amendments to classification
of pressure equipment. It is of particular importance that the Commission carry
out appropriate consultations during its preparatory work, including at expert
level.

(52)     The
Commission, when preparing and drawing-up delegated acts, should ensure a
simultaneous, timely and appropriate transmission of relevant documents to the
European Parliament and to the Council.

(53)     Directive
97/23/EC provides for a transitional arrangement enabling pressure equipment and
assemblies which comply with the national regulations in force on the date of application
of Directive 97/23/EC to be put into service. For reasons of legal certainty,
it is necessary to include that transitional arrangement also in this
Directive.

(54)     It
is necessary to provide for transitional arrangements that allow the making
available on the market and the putting into service of pressure equipment
which complies with Directive 97/23/EC.

(55)     Member
States should lay down rules on penalties applicable to infringements of the
provisions of national law adopted pursuant to this Directive and ensure that they
are implemented. Those penalties must be effective, proportionate and
dissuasive.

(56)     Since the objective of this Directive, namely to
ensure that pressure equipment on the market fulfils the requirements providing
a high level of protection of health and safety of users and protection of
domestic animals or property while guaranteeing the functioning of the internal
market cannot be sufficiently achieved by the Member States and can therefore,
by reason of its scale and effects, be better achieved at Union level, the
Union may adopt measures, in accordance with the principle of subsidiarity as
set out in Article 5 of the Treaty on European Union. In accordance with the principle
of proportionality, as set out in that Article, this Directive does not go
beyond what is necessary in order to achieve that objective.

(57)     The obligation to transpose this Directive into
national law should be confined to those provisions which represent a
substantive change as compared with Directive 97/23/EC. The obligation to
transpose the provisions which are unchanged arises under Directive 97/23/EC.

(58)     This Directive should be without prejudice to the
obligations of the Member States relating to the time-limits for transposition
into national law and application of Directive 97/23/EC set out in Part B of Annex
V,

ê 97/23/EC
(adapted)

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER 1

Ö GENERAL PROVISIONS Õ

Article 1

Scope and definitions

1. This Directive applies Ö shall
apply Õ to the design,
manufacture and conformity assessment of pressure equipment and assemblies with
a maximum allowable pressure PS greater than 0,5 bar.

32. The following are excluded from the scope of
Tthis Directive Ö shall not
apply to Õ :

ê 97/23/EC
(adapted)

3.1.(a)  pipelines comprising piping or a system of piping designed for the
conveyance of any fluid or substance to or from an installation (onshore or
offshore) starting from and including the last isolation device located within
the confines of the installation, including all the annexed equipment designed
specifically for pipelines;, Tthis exclusion does Ö shall Õ not apply to
standard pressure equipment such as may be found in pressure reduction stations
or compression stations;

3.2.(b)  networks for the supply, distribution and discharge of water and
associated equipment and headraces such as penstocks, pressure tunnels,
pressure shafts for hydroelectric installations and their related specific
accessories;

ê 97/23/EC
(adapted)

3.3.(c)  equipment
Ö simple
pressure vessels Õ covered by
Directive 87/404/EEC 2009/105/EC of the European Parliament and of the Council[28] on
simple pressure vessels;

3.4.(d)  equipment
Ö aerosol
dispensers Õ covered by
Council Directive 75/324/EEC[29]
of
20 May 1975 on the approximation of the laws of the Member States relating to
aerosol dispensers;

3.5.(e)  equipment intended for the functioning of vehicles defined by the
following Directives and their Annexes:

ê 97/23/EC (adapted)

(i)      Directive 70/156/EEC of 6 February 1970
2007/46/EC of the European Parliament and of
the Council[30]
on
the approximation of the laws of the Member States relating to the
type-approval of motor vehicles and their trailers establishing a framework for the approval of motor
vehicles and their trailers, and of systems, components and separate technical
units intended for such vehicles,;

(ii)     Directive 74/150/EEC 2003/37/EC of the European Parliament and of the Council[31] 4
March 1974 on the approximation of the laws of the
Member States relating to the type-approval of wheeled
agricultural or forestry tractors,
their trailers and interchangeable towed
machinery, together with their systems, components and separate technical units,;

(iii)     Directive 92/61/EEC 2002/24/EC of the European Parliament and of the Council[32] 30
June 1992 relating to the type-approval of two or
three-wheel motor vehicles;

3.6.(f)   equipment classified as no higher than category I under Article 9
of this Directive and covered by one of the following Directives:

(i)      Directive 89/392/EEC 2006/42/EC of the European Parliament and of the Council[33] 14
June 1989 on the approximation of the laws of the
Member States relating to machinery,;

(ii)     Directive 95/16/EC of 29 June 1995 the European Parliament and of the Council[34] on the
approximation of the laws of the Member States relating to
lifts,;

(iii)     Directive 73/23/EEC 2006/95/EC of the European Parliament and of the Council[35] 19
February 1973 on the harmonisation
of the laws of the Member States relating to electrical
equipment designed for use within certain voltage limits,;

(iv)    Council Directive 93/42/EEC of 14 June 1993 concerning
medical devices[36],;

(v)     Directive 90/396/EEC 2009/142/EC of the European Parliament and of the Council[37] 29
June 1990 on
the approximation of the laws of the Member States
relating to appliances burning gaseous fuels,;

(vi)    Directive 94/9/EC of the European Parliament and of the Council[38] of
23 March 1994 on the approximation of the laws of the Member States
concerning equipment and protective systems intended for use in potentially
explosive atmospheres;

3.7.(g)  equipment covered by Article 223 Ö 346 Õ (1) (b) of the
Treaty;

3.8.(h)  items specifically designed for nuclear use, failure of which may
cause an emission of radioactivity;

3.9.(i)   well-control equipment used in the petroleum, gas or geothermal
exploration and extraction industry and in underground storage which is
intended to contain and/or control well pressure;,
Tthis Ö shall Õ comprises the
wellhead (Christmas tree), the blow out preventers (BOP), the piping manifolds
and all their equipment upstream;

3.10.(j) equipment comprising casings or machinery where the dimensioning,
choice of material and manufacturing rules are based primarily on requirements
for sufficient strength, rigidity and stability to meet the static and dynamic
operational effects or other operational characteristics and for which pressure
is not a significant design factor;, Ssuch equipment may include:

(i)      engines including turbines and internal combustion engines;

(ii)     steam engines, gas/steam turbines, turbo-generators,
compressors, pumps and actuating devices;.

3.11.(k) blast furnaces including the furnace cooling system, hot-blast
recuperators, dust extractors and blast-furnace exhaust-gas scrubbers and
direct reducing cupolas, including the furnace cooling, gas converters and pans
for melting, re-melting, de-gassing and casting of steel and non-ferrous
metals;

3.12.(l) enclosures for high-voltage electrical equipment such as switchgear,
control gear, transformers, and rotating machines;

3.13.(m) pressurized pipes for the containment of transmission systems, e.g.
for electrical power and telephone cables;

3.14.(n) ships, rockets, aircraft and mobile off-shore units, as well as
equipment specifically intended for installation on board or the propulsion
thereof;

3.15.(o) pressure equipment consisting of a flexible casing, e.g. tyres, air
cushions, balls used for play, inflatable craft, and other similar pressure
equipment;

3.16.(p) exhaust and inlet silencers;

3.17.(q) bottles or cans for carbonated drinks for final consumption;

3.18.(r)            vessels designed for the transport and distribution of
drinks having a PS·V of not more than 500 bar·L and a maximum allowable
pressure not exceeding 7 bar;

ê 97/23/EC
(adapted)

3.19.(s) equipment covered by Ö Directive
2008/68/EC and Directive 2010/35/EU and equipment covered by Õ ADR[39], the RID[40], the Ö International
Maritime Dangerous Goods Code Õ (IMDG)[41]
and the Ö Convention on International
Civil Aviation Õ (ICAO Convention)[42];

ê 97/23/EC

3.20.(t) radiators and pipes in warm water heating systems;

3.21.(u) vessels designed to contain liquids with a gas pressure above the
liquid of not more than 0,5 bar.

ê 97/23/EC
(adapted)

Article
2

Ö Definitions Õ

For the purposes of this Directive Ö the
following definitions apply Õ :

2.1.(1) ‘Ppressure
equipment’ means vessels, piping, safety accessories and pressure accessories., Ö including,
Õ Wwhere applicable, pressure equipment includes
elements attached to pressurized parts, such as flanges, nozzles, couplings,
supports, lifting lugs, etc.;

ê 97/23/EC

2.1.1.(2) ‘Vvessel’
means a housing designed and built to contain fluids under pressure including
its direct attachments up to the coupling point connecting it to other
equipment;,
Aa vessel may be composed of more than
one chamber.;

2.1.2.(3) ‘Ppiping’
means piping components intended for the transport of fluids, when connected
together for integration into a pressure system;,
Ppiping includes in particular a pipe or
system of pipes, tubing, fittings, expansion joints, hoses, or other
pressure-bearing components as appropriate;, Hheat exchangers consisting of pipes for
the purpose of cooling or heating air shall be considered as piping.;

ê 97/23/EC
(adapted)

2.1.3.(4) ‘Ssafety
accessories’ means devices designed to protect pressure equipment against the
allowable limits being exceeded., Such devices include
Ö including Õ devices for
direct pressure limitation, such as safety valves, bursting disc safety
devices, buckling rods, controlled safety pressure relief systems (CSPRS), and limiting
devices, which either activate the means for correction or provide for shutdown
or shutdown and lockout, such as pressure switches or temperature switches or
fluid level switches and «safety related measurement control and regulation
(SRMCR)» devices.;

ê 97/23/EC

2.1.4.(5) ‘Ppressure
accessories’ means devices with an operational function and having
pressure-bearing housings.;

2.1.5.(6) ‘Aassemblies’
means several pieces of pressure equipment assembled by a manufacturer to
constitute an integrated and functional whole.;

2.2.(7) ‘Ppressure»
means pressure relative to atmospheric pressure, i.e. gauge pressure. As a
consequence, vacuum is designated by a negative value.;

2.3.(8) ‘Mmaximum
allowable pressure PS’ means the maximum pressure for which the equipment is
designed, as specified by the manufacturer.,

ê 97/23/EC
(adapted)

It is Ö and Õ defined at a
location specified by the manufacturer Ö him,
being either Õ .
This must be the
location of Ö the Õ connection of
protective and/or limiting devices,
or the top of equipment or, if not
appropriate, any point specified.

ê 97/23/EC

2.4.(9) ‘Mmaximum/minimum
allowable temperature TS’ means the maximum/minimum temperatures for which the
equipment is designed, as specified by the manufacturer.;

2.5.(10) ‘Vvolume
(V)’ means the internal volume of a chamber, including the volume of nozzles to
the first connection or weld and excluding the volume of permanent internal
parts.;

2.6.(11) ‘Nnominal
size (DN)’ means a numerical designation of size which is common to all
components in a piping system other than components indicated by outside
diameters or by thread size;, Iit is a convenient round number for
reference purposes and is only loosely related to manufacturing dimensions;,
Tthe nominal size is designated by DN
followed by a number.;

2.7.(12) ‘Ffluids’
means gases, liquids and vapours in pure phase as well as mixtures thereof. A
fluid may contain a suspension of solids.;

2.8.(13) ‘Ppermanent
joints’ means joints which cannot be disconnected except by destructive methods.;

2.9.(14) ‘European approval for materials’ means a technical document
defining the characteristics of materials intended for repeated use in the
manufacture of pressure equipment which are not covered by any harmonised
standard.;

ò new

(15)      ‘making
available on the market’ means any supply of pressure equipment for
distribution or use on the Union market in the course of a commercial activity,
whether in return for payment or free of charge;

(16)      ‘placing
on the market’ means the first making available of pressure equipment on the
Union market;

(17)      ‘manufacturer’
means any natural or legal person who manufactures pressure equipment or has such
equipment designed or manufactured, and markets that product under his name or
trademark;

(18)      ‘authorised
representative’ means any natural or legal person established within the Union
who has received a written mandate from a manufacturer to act on his behalf in
relation to specified tasks;

(19)      ‘importer’
means any natural or legal person established within the Union who places
pressure equipment from a third country on the Union market;

(20)      ‘distributor’
means any natural or legal person in the supply chain, other than the
manufacturer or the importer, who makes pressure equipment available on the
market;

(21)      ‘economic
operators’ means the manufacturer, the authorised representative, the importer
and the distributor;

(22)      ‘technical
specification’ means a document that prescribes technical requirements to be
fulfilled by pressure equipment, process or service;

(23)      ‘harmonised
standard’ means harmonised standard as defined in Article 2(1)(c) of Regulation
(EU) No 1025/2012;

(24)      ‘accreditation’
means accreditation as defined in Article 2(10) of Regulation (EC) No 765/2008;

(25)      ‘national
accreditation body’ means national accreditation body as defined in Article
2(11) of Regulation (EC) No 765/2008;

(26)      ‘conformity
assessment’ means the process demonstrating whether the requirements of this
Directive relating to pressure equipment, process, service, or a system have
been fulfilled;

(27)      ‘conformity
assessment body’ means a body that performs conformity assessment activities
including calibration, testing, certification and inspection;

(28)      ‘recall’
means any measure aimed at achieving the return of pressure equipment that has
already been made available to the user;

(29)      ‘withdrawal’
means any measure aimed at preventing pressure equipment in the supply chain
from being made available on the market;

(30)      ‘CE
marking’ means a marking by which the manufacturer indicates that the pressure
equipment and/or the assembly is in conformity with the applicable requirements
set out in Union harmonisation legislation providing for its affixing;

(31)      ‘Union
harmonisation legislation’ means any Union legislation harmonising the
conditions for the marketing of products.

ê 97/23/EC
(adapted)

ð new

Article 23

Market
surveillance Ö Making available on the market and
putting into service Õ

1. Member States shall take all appropriate
measures to ensure that the pressure equipment and the assemblies referred to in Article 1
may be placed ð made available ï on the market and put into service only if, when properly installed and maintained and used
for their intended purpose, they do not endanger the health and safety of
persons and, where appropriate, domestic animals or property
ð they satisfy the requirements of
this Directive ï .

2. The provisions of Tthis Directive
shall not affect Member States' entitlement to lay down, with due regard to the provisions of the Treaty,
such requirements as they may deem necessary to ensure that persons and, in
particular, workers are protected during use of the pressure equipment or assemblies
in question provided that this does not mean modifications to such equipment or assemblies
in a way not specified in this Directive.

3. At trade fairs, exhibitions,
demonstrations,
etc., Ö and other
similar events, Õ Member States
shall not prevent the showing of pressure equipment or assemblies as defined in Article 1 not in
conformity Ö which do
not comply Õ with the provisions of
this Directive, provided that a visible sign clearly indicates their
non-conformity and their non-availability for sale until Ö they
are Õ brought into
conformity by the manufacturer or by his authorized representative established within the
Community. During demonstrations, appropriate safety measures
shall be taken in accordance with any requirements laid down by the competent
authority of the Member State concerned in order to ensure the safety of
persons.

Article 34

Technical
requirements

1. The Ö following Õ pressure
equipment referred
to in 1.1, 1.2, 1.3 and 1.4 must satisfy the essential Ö safety Õ requirements
set out in Annex I:

ê 97/23/EC

è1 Corrigendum 97/23/EC

1.1.(a)  Vvessels,
except those referred to in 1.2 point (b) for:

(ai)    gases, liquefied gases, gases
dissolved under pressure, vapours and also those liquids whose vapour pressure
at the maximum allowable temperature is greater than 0,5 bar above normal
atmospheric pressure, (1013 mbar) within the following limits:

– 
for fluids in Group 1 with a volume greater than
1 L and a product of PS and V greater than 25 bar·L, or with a pressure PS
greater than 200 bar (Annex II, table 1),;

– 
for fluids in Group 2, with a volume greater
than 1 L and a product of PS and V is greater than 50 bar·L, or with a
pressure PS greater than 1000 bar, and all portable extinguishers and bottles
for breathing apparatus (Annex II, table 2);

(bii)   liquids having a vapour pressure
at the maximum allowable temperature of not more than 0,5 bar above normal
atmospheric pressure (1013 mbar) within the following limits:

– 
for fluids in Group 1 with a volume greater than
1 L and a product of PS and V greater than 200 bar·L, or with a pressure
PS greater than 500 bar (Annex II, table 3),;

– 
for fluids in Group 2 with a pressure PS greater
than 10 bar and a product of PS and V greater than 10000 bar·L, or with a
pressure PS greater than 1000 bar (Annex II, table 4).

1.2.(b)  Ffired
or otherwise heated pressure equipment with the risk of overheating intended
for generation of steam or super-heated water at temperatures higher than è1 110 °C ç having a
volume greater than 2 L, and all pressure cookers (Annex II, table 5).

1.3.(c)  Ppiping
intended for:

(ai)    gases, liquefied gases, gases
dissolved under pressure, vapours and those liquids whose vapour pressure at
the maximum allowable temperature is greater than 0,5 bar above normal
atmospheric pressure (1013 mbar) within the following limits:

– 
for fluids in Group 1 with a DN greater than 25
(Annex II, table 6),;

– 
for fluids in Group 2 with a DN greater than 32
and a product of PS and DN greater than 1000 bar (Annex II, table 7);

(bii)   liquids having a vapour pressure
at the maximum allowable temperature of not more than 0,5 bar above normal
atmospheric pressure (1013 mbar), within the following limits:

– 
for fluids in Group 1 with a DN greater than 25
and a product of PS and DN greater than 2000 bar (Annex II, table 8),;

– 
for fluids in Group 2 with a PS greater than 10
bar, a DN greater than 200 and a product of PS and DN greater than 5000 bar
(Annex II, table 9).

ê 97/23/EC
(adapted)

1.4.(d)  Ssafety
and pressure accessories intended for equipment covered by 1.1,
1.2 and 1.3 subparagraphs
(a), (b), and (c) including where such equipment is incorporated
into an assembly.

2. The Ö following Õ assemblies defined in Article 1, section
2.1.5, which include at least one item of pressure
equipment covered by section paragraph 1 of this Article and which are listed in 2.1, 2.2
and 2.3 of this Article must satisfy the essential Ö safety Õ requirements
set out in Annex I.

ê 97/23/EC

è1 Corrigendum 97/23/EC

ð new

2.1.(a)  Aassemblies
intended for generating steam or superheated water at a temperature higher than
è1 110 °C ç comprising
at least one item of fired or otherwise heated pressure equipment presenting a
risk of overheating.

2.2.(b)  Aassemblies
other than those referred to in 2.1 point (a), if the manufacturer intends
them to be placed ð made available ï on the market and put into service as assemblies.

ê 97/23/EC
(adapted)

ð new

2.3.      By way of derogation from the first
subparagraph introductory paragraph to
this section, assemblies intended for generating warm
water at temperatures not greater than 110 °C which are manually fed with
solid fuels and have a PS·V greater than 50 bar·L must comply with the
essential Ö safety Õ requirements
referred to in points 2.10, 2.11,
3.4, 5 (a) and 5 (d) of Annex I.

3. Pressure equipment and/or assemblies
below or equal to the limits Ö set
out Õ in sections
1.1, 1.2 points (a),
(b) and (c) of paragraph 1 and in paragraph 2 and
1.3 and section 2 respectively must Ö shall Õ be designed
and manufactured in accordance with the sound engineering practice of a Member
State in order to ensure safe use. Pressure equipment and/or assemblies must be
accompanied by adequate instructions for use and must bear markings to permit identification of the
manufacturer or of his authorized representative established within the
Community. Such equipment and/or assemblies must Ö shall Õ not bear the
CE marking referred to in Article 1518.

Article 45

Free movement

1.         1.1.
Member States shall not, on grounds of the hazards Ö risks Õ due to
pressure, prohibit, restrict or impede the placing
ð making available ï on the market or Ö the Õ putting into
service under the conditions specified by the manufacturer of pressure
equipment or
assemblies referred to in Article 1 which comply with this
Directive and bear the CE marking indicating that they have
undergone conformity assessment in accordance with Article 10.

1.2.      Member States shall not, on grounds of the hazards
Ö risks Õ due to
pressure, prohibit, restrict or impede the placing
ð making available ï on the market or Ö the Õ putting into
service of pressure equipment or assemblies which comply with Article 34(3).

2. Member States may require, to the extent
that it is needed for safe and correct use of pressure equipment and assemblies,
the information referred to in Annex I sections points 3.3 and 3.4 of Annex I to be provided in the
official language(s) of the Community Ö Union Õ which may be
determined in
accordance with the Treaty by the Member State in
which the equipment or
assembly reaches the final user.

14.2.3. When a Member State has
designated a user inspectorate in accordance with the criteria Ö requirements Õ set out in this Article ð 25 ï , it may not, on grounds of the hazards Ö risks Õ due to
pressure, prohibit, restrict or impede the placing on the market or putting
into service under the conditions provided for in this
Article 16, of pressure equipment or assemblies
the conformity of which has been assessed by a user inspectorate designated by
another Member State in accordance with the criteria Ö requirements Õ set out in this Article ð 25 ï .

ò new

CHAPTER 2

OBLIGATIONS OF
ECONOMIC OPERATORS

Article 6 [Article
R2 of Decision No 768/2008/EC]

Obligations of manufacturers

1.         When
placing their pressure equipment referred to in Article 4(1) and (2) on the
market, manufacturers shall ensure that they have been designed and
manufactured in accordance with the essential safety requirements set out in Annex
I.

When placing
their pressure equipment referred to in Article 4(3) on the market,
manufacturers shall ensure that they have been designed and manufactured in accordance
with the sound engineering practice of a Member State.

2.         For
pressure equipment referred to in Article 4(1) and (2), manufacturers shall
draw up the technical documentation referred to in Annex II and carry out the
conformity assessment procedure referred to in Article 14 or have it carried
out.

Where compliance
of pressure equipment referred to in Article 4(1) and (2), with the applicable
requirements has been demonstrated by the procedure referred to in the first
subparagraph, manufacturers shall draw up an EU declaration of
conformity and affix the CE marking.

3.         Manufacturers
shall keep the technical documentation and the EU declaration of conformity for
10 years after the pressure equipment has been placed on the market.

4.         Manufacturers
shall ensure that procedures are in place for series production to remain in
conformity. Changes in pressure equipment design or characteristics and changes
in the harmonised standards or in other technical specifications by reference
to which conformity of pressure equipment is declared shall be adequately taken
into account.

When deemed
appropriate with regard to the risks presented by pressure equipment,
manufacturers shall, to protect the health and safety of consumers and other users,
carry out sample testing of pressure equipment made available on the market,
investigate, and, if necessary, keep a register of complaints of non-conforming
pressure equipment and recalls of such equipment, and shall keep distributors
informed of any such monitoring.

5.         Manufacturers
shall ensure that their pressure equipment bear a type, batch or serial number
or other element allowing their identification, or, where the size or nature of
the equipment does not allow it, that the required information is provided on
the packaging or in a document accompanying the equipment.

6.         Manufacturers
shall indicate their name, registered trade name or registered trade mark, the postal
address, and, if available, the website address at which they can be contacted
on the pressure equipment or, where that is not possible, on their packaging or
in a document accompanying the equipment. The address must indicate a single
point at which the manufacturer can be contacted.

7.         Manufacturers
shall ensure that the pressure equipment referred to in Article 4(1) and (2), is
accompanied by instructions and safety information in accordance with points 3.3
and 3.4 of Annex I, in a language which can be easily understood by consumers
and other users, as determined by the Member State concerned. Such instructions
and safety information shall be clear, understandable and intelligible.

Manufacturers
shall ensure that the pressure equipment referred to in Article 4(3), is
accompanied by instructions and safety information in accordance with Article 4(3),
in a language which can be easily understood by consumers and other users, as
determined by the Member State concerned. Such instructions and safety
information shall be clear, understandable and intelligible.

8.         Manufacturers
who consider or have reason to believe that the pressure equipment which they
have placed on the market is not in conformity with this Directive shall
immediately take the necessary corrective measures necessary to bring that
pressure equipment into conformity, to withdraw it or recall it, if
appropriate. Furthermore, where the pressure equipment presents a risk,
manufacturers shall immediately inform the competent national authorities of
the Member States in which they made the pressure equipment available on the
market to that effect, giving details, in particular, of the noncompliance and
of any corrective measures taken.

9.         Manufacturers
shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation necessary to demonstrate
the conformity of the pressure equipment with this Directive, in a language
which can be easily understood by that authority. That information and
documentation may be provided in paper or electronic form. They shall cooperate
with that authority, at its request, on any action taken to eliminate the risks
posed by the pressure equipment which they have placed on the market.

Article 7 [Article
R3 of Decision No 768/2008/EC]

Authorised representatives

1.         A
manufacturer may, by a written mandate, appoint an authorised representative.

The obligations
laid down in Article 6(1) and the drawing up of technical documentation shall
not form part of the authorised representative's mandate.

2.         An
authorised representative shall perform the tasks specified in the mandate
received from the manufacturer. The mandate shall allow the authorised
representative to do at least the following:

(a)     keep the EU
declaration of conformity and the technical documentation at the disposal of
national surveillance authorities for 10 years after the pressure equipment has
been placed on the market;

(b)     further to a
reasoned request from a competent national authority, provide that authority
with all the information and documentation necessary to demonstrate the
conformity of the pressure equipment;

(c)     cooperate
with the competent national authorities, at their request, on any action taken
to eliminate the risks posed by pressure equipment covered by the authorised
representative’s mandate.

Article 8 [Article
R4 of Decision No 768/2008/EC]

Obligations of importers

1.         Importers
shall place only compliant pressure equipment on the market.

2.         Before
placing on the market pressure equipment referred to in Article 4(1) and (2),
importers shall ensure that the appropriate conformity assessment procedure in
accordance with Article 14 has been carried out by the manufacturer. They shall
ensure that the manufacturer has drawn up the technical documentation, that the
pressure equipment bears the CE marking and is accompanied by instructions and
safety information in accordance with points 3.3 and 3.4 of Annex I, and that
the manufacturer has complied with the requirements set out in Article 6(5) and
(6).

Before placing on
the market pressure equipment referred to in Article 4(3), importers shall ensure
that the manufacturer has drawn up the technical documentation and that the
pressure equipment is accompanied by adequate instructions for use and that the
manufacturer has complied with the requirements set out in Article 6(5) and
(6).

Where an importer
considers or has reason to believe that pressure equipment is not in conformity
with the essential safety requirements set out in Annex I, he shall not place
the pressure equipment on the market until it has been brought into conformity.
Furthermore, where the pressure equipment presents a risk, the importer shall
inform the manufacturer and the market surveillance authorities to that effect.

3.         Importers
shall indicate their name, registered trade name or registered trade mark and the
postal address at which they can be contacted on the pressure equipment or,
where that is not possible, on its packaging or in a document accompanying the equipment.
The contact details shall be in a language easily understood by users and
market surveillance authorities.

4.         Importers
shall ensure that pressure equipment referred to in Article 4(1) and (2) is
accompanied by instructions and safety information in accordance with points 3.3
and 3.4 of Annex I, in a language which can be easily understood by consumers
and other users, as determined by the Member State concerned.

Importers shall
ensure that the pressure equipment referred to in Article 4(3) is accompanied
by instructions and safety information in a language which can be easily
understood by consumers and other users, as determined by the Member State
concerned.

5.         Importers
shall ensure that, while pressure equipment referred to in Article 4(1) and (2)
is under their responsibility, storage or transport conditions do not
jeopardise its compliance with the requirements set out in Annex I.

6.         When
deemed appropriate with regard to the risks presented by pressure equipment,
importers shall, to protect the health and safety of consumers and other users,
upon a duly justified request of the competent authorities, carry out sample
testing of pressure equipment made available on the market, investigate, and,
if necessary, keep a register of complaints, non-conforming pressure equipment
and recalls of such equipment, and shall keep distributors informed of any such
monitoring.

7.         Importers
who consider or have reason to believe that pressure equipment which they have
placed on the market is not in conformity with this Directive shall immediately
take the corrective measures necessary to bring that pressure equipment into
conformity, to withdraw it or recall it, if appropriate. Furthermore, where the
pressure equipment presents a risk, importers shall immediately inform the
competent national authorities of the Member States in which they made the
pressure equipment available on the market to that effect, giving details, in
particular, of the noncompliance and of any corrective measures taken.

8.         Importers
shall, for 10 years after the pressure equipment has been placed on the market,
keep a copy of the EU declaration of conformity at the disposal of the market
surveillance authorities and ensure that the technical documentation can be
made available to those authorities, upon request.

9.         Importers
shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation necessary to demonstrate
the conformity of pressure equipment in a language which can be easily
understood by that authority. That information and documentation may be
provided in paper or electronic form. They shall cooperate with that authority,
at its request, on any action taken to eliminate the risks posed by pressure
equipment which they have placed on the market.

Article 9 [Article
R5 of Decision No 768/2008/EC]

Obligations of distributors

1.         When
making pressure equipment available on the market distributors shall act with
due care in relation to the requirements of this Directive.

2.         Before
making pressure equipment referred to in Article 4(1) and (2) available on the
market distributors shall verify that the pressure equipment bears the CE
marking, that it is accompanied by the required documents and by instructions
and safety information in accordance with points 3.3 and 3.4 of Annex I, in a
language which can be easily understood by consumers and other users in the
Member State in which the pressure equipment is to be made available on the
market, and that the manufacturer and the importer have complied with the
requirements set out in Article 6(5) and (6) and Article 8(3).

Where a
distributor considers or has reason to believe that pressure equipment is not
in conformity with the essential safety requirements set out in Annex I, he
shall not make the pressure equipment available on the market until it has been
brought into conformity. Furthermore, where the pressure equipment presents a
risk, the distributor shall inform the manufacturer or the importer to that
effect as well as the market surveillance authorities.

Before making
pressure equipment referred to in Article 4(3) available on the market distributors
shall verify that the pressure equipment is accompanied by adequate
instructions for use, in a language which can be easily understood by consumers
and other users in the Member State in which the pressure equipment is to be
made available on the market, and that the manufacturer and the importer have
complied with the requirements set out in Article 6(5) and (6) and Article 8(3).

3.         Distributors
shall ensure that, while pressure equipment referred to in Article 4(1) and (2)
is under their responsibility, storage or transport conditions do not
jeopardise their/its compliance with the essential safety requirements set out
in Annex I.

4.         Distributors
who consider or have reason to believe that pressure equipment which they have
made available on the market is not in conformity with this Directive shall
make sure that the corrective measures necessary to bring that equipment into
conformity, to withdraw it or recall it, if appropriate, are taken.
Furthermore, where the pressure equipment presents a risk, distributors shall
immediately inform the competent national authorities of the Member States in
which they made the equipment available to that effect, giving details, in
particular, of the non-compliance and of any corrective measures taken.

5.         Distributors
shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation necessary to demonstrate
the conformity of pressure equipment. That information and documentation may be
provided in paper or electronic form. They shall cooperate with that authority,
at its request, on any action taken to eliminate the risks posed by the pressure
equipment which they have made available on the market.

Article 10 [Article
R6 of Decision No 768/2008/EC]

Cases in which obligations of manufacturers apply to importers and
distributors

An importer or
distributor shall be considered a manufacturer for the purposes of this
Directive and he shall be subject to the obligations of the manufacturer under
Article 6, where he places pressure equipment on the market under his name or
trademark or modifies pressure equipment already placed on the market in such a
way that compliance with the requirements of this Directive may be affected.

Article 11 [Article
R7 of Decision No 768/2008/EC]

Identification of economic operators

Economic
operators shall, on request, identify the following to the market surveillance
authorities, for 10 years:

(a) any economic
operator who has supplied them with pressure equipment;

(b) any economic
operator to whom they have supplied pressure equipment.

Economic
operators shall be able to present the information referred to in the first
paragraph for a period of 10 years after they have been supplied with the
pressure equipment and for a period of 10 years after they have supplied the
pressure equipment.

CHAPTER 3

CONFORMITY AND
CLASSIFICATION OF PRESSURE EQUIPMENT

ê 97/23/EC

Article 512 [Article R8 of Decision No
768/2008/EC]

Presumption
of conformity

ò new

1. Pressure equipment referred to in
Article 4(1) and (2) which are in conformity with harmonised standards
or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in
conformity with the essential safety requirements covered by those standards or
parts thereof, referred to in Annex I.

ê 97/23/EC
(adapted)

1.2. Member States shall regard pressure equipment and assemblies
bearing the CE marking provided for in Article 1518 and the EC Ö EU Õ declaration of
conformity provided for in Annex VII Article 17 as conforming to all the provisions of
this Directive,
including the conformity assessment provided for in Article 10.

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2. Pressure
equipment and assemblies which conform to the national standards transposing
the harmonized standards the reference numbers of which have been published in
the Official Journal of the European Communities shall be presumed to conform
to the essential requirements referred to in
Article 3. Member States shall publish the reference numbers of the national
standards referred to above.

3. Member States
shall ensure that appropriate measures are taken to enable both sides of
industry to have an input at national level in the process of preparing and
monitoring the harmonized standards.

ê 97/23/EC
(adapted)

4.3. The materials used for the manufacture of pressure equipment conforming
Ö which are
in conformity Õ with European
approvals for materials, the references of which have been published in the Official
Journal of the European Communities Ö Union
in accordance with Article 15(4), Õ shall be
presumed to conform
to Ö be in conformity
with Õ the applicable
essential Ö safety Õ requirements of Ö set out
in Õ Annex I.

Article 913

Classification of pressure
equipment

1. Pressure equipment referred to in
Article 34(1)
shall be classified by category in accordance with Annex II, according to
ascending level of hazard
Ö risk Õ .

For the purposes of such classification
fluids shall be divided into Ö the
following Õ two groups: in accordance with 2.1 and 2.2.

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2.1.      Group
1 comprises dangerous fluids. A dangerous fluid is a substance or preparation
covered by the definitions in Article 2 (2) of Council Directive 67/548/EEC of
27 June 1967 on the approximation of the
laws, regulations and administrative provisions relating to the classification,
packaging and labelling of dangerous substances[43].

Group
1 comprises fluids defined as:

– 
explosive,

– 
extremely
flammable,

– 
highly flammable,

– 
flammable (where
the maximum allowable temperature is above flashpoint),

– 
very toxic,

– 
toxic,

– 
oxidizing.

ò new

(a) group 1 that comprises
fluids consisting of substances and mixtures, as defined in points (7) and (8)
of Article 2 of Regulation (EC) No 1272/2008, that are classified as hazardous in
accordance with the following physical or health hazard classes laid down in
Parts 2 and 3 of Annex I to that Regulation:

(i)      unstable explosives
or explosives of Divisions 1.1, 1.2, 1.3, 1.4 and 1.5;

(ii)     flammable
gases, category 1 and 2;

(iii)     oxidising
gases, category 1;

(iv)    flammable
liquids, categories 1 and 2;

(v)     flammable
liquids, category 3 where the maximum allowable temperature is above the
flashpoint;

(vi)    flammable
solids, category 1 and 2;

(vii)    self-reactive
substances and mixtures, type A to F;

(viii)   pyrophoric
liquids, category 1;

(ix)    pyrophoric
solids, category 1;

(x)     substances
and mixtures which in contact with water emit flammable gases, category 1, 2
and 3;

(xi)    oxidising
liquids, category 1, 2 and 3;

(xii)    oxidising
solids, category 1, 2 and 3;

(xiii)   organic
peroxides types A to F;

(xiv)   acute oral toxicity:
category 1 and 2;

(xv)   acute dermal
toxicity: category 1 and 2;

(xvi)   acute
inhalation toxicity: category 1, 2 and 3;

(xvii)  specific
target organ toxicity – single exposure: category 1.

ê 97/23/EC
(adapted)

2.2.(b)  Ggroup
2 Ö that Õ comprises all
other fluids not referred to in 2.1 point (a).

ê 97/23/EC

3.2. Where a vessel is composed of a number of chambers, it shall be
classified in the highest category applicable to the individual chambers. Where
a chamber contains several fluids, classification shall be on the basis of the
fluid which requires the highest category.

ê 97/23/EC
(adapted)

Article 1014

Conformity assessment

1.         1.1. Before placing pressure equipment on the
market, the manufacturer shall subject each item of equipment to one of the
conformity assessment procedures described in Annex III, according to the
conditions given in this Article.

1.2.1.   The conformity assessment procedures to be applied to an item of
pressure equipment with a view to affixing the CE
marking shall be determined by the category, as defined
Ö set out Õ in Article 913, in which the equipment is
classified.

1.3.2.   The conformity assessment procedures to be applied for the
various categories are as follows Ö the
following Õ :

ê 97/23/EC

(a)        category I:

– 
Module A

(b)        category II:

– 
Module A12

– 
Module D1

– 
Module E1

(c)        category III:

ê 97/23/EC
(adapted)

– 
Module B1 Ö (design
type) Õ + D

– 
Module B1 Ö (design
type) Õ + F

– 
Module B Ö (combination
of production type and design type) Õ + E

– 
Module B Ö (combination
of production type and design type) Õ + C12

ê 97/23/EC

– 
Module H

(d)        category IV:

ê 97/23/EC
(adapted)

– 
Module B Ö (combination
of production type and design type) Õ + D

– 
Module B Ö (combination
of production type and design type) Õ + F

ê 97/23/EC
(adapted)

– 
Module G

– 
Module H1

Ö The conformity
assessment procedures are set out in Annex III. Õ

1.4.3.   Pressure equipment shall be subjected to one of the
conformity assessment procedures which may be chosen by the manufacturer among
those laid down for the category in which it is classified. The manufacturer
may also choose to apply one of the procedures which apply to a higher
category, if available.

1.5.4.   In the framework of quality assurance procedures for Ö pressure Õ equipment in
categories III and IV referred to in Article 34(1)(a)(i), section
1.1 (a), section1 first indent of Article 4(1)(ba)(ii)
and 3
Article 4(1)(b) section
1.2, the notified body shall, when performing unexpected
visits, take a sample of equipment from the manufacturing or storage premises
in order to perform, or have performed, the final assessment as referred to in
Annex I, section point
3.2.2. To this end, the manufacturer shall inform the notified body of the
intended schedule of production. The notified body shall carry out at least two
visits during the first year of manufacturing. The frequency of subsequent
visits shall be determined by the notified body on the basis of the criteria
set out in section point
4.4 of the relevant modules.

1.6.5.   In the case of one-off production of vessels and Ö pressure Õ equipment in
Category III referred to in Article 34(1)(b), section 1.2
under the module H procedure, the notified body shall perform or have performed
the final assessment, as referred to in Annex I, section
point 3.2.2 of Annex I, for each unit. To this end,
the manufacturer shall communicate the intended schedule of production to the
notified body.

ê 97/23/EC
(adapted)

2.6. Assemblies referred to in Article 34(2) shall be subjected
to a global conformity assessment procedure comprising Ö the
following assessments Õ :

ê 97/23/EC
(adapted)

ð new

(a)        Ö the Õ assessment of
each item of pressure equipment making up the assembly and referred to in
Article 34(1)
which has not been previously subjected to a conformity assessment
procedure and to a separate CE marking; the assessment procedure shall be
determined by the category of each item of equipment;

(b)        the assessment of the
integration of the various components of the assembly as referred to in sections
points 2.3, 2.8 and 2.9 of Annex I
which shall be determined by the highest category applicable to the equipment
concerned other than that applicable to any safety accessories;

(c)        the assessment of the protection
of an assembly against exceeding the permissible operating limits as referred
to in sections
points 2.10 and 3.2.3 of Annex I
shall be conducted in the light of the highest category applicable to the items
of equipment to be protected.

3.7. By way of derogation from paragraphs 1 and 2, the competent
authorities may, where justified, allow the placing
ð making available ï on the market and putting into service in the territory of the
Member State concerned of individual pressure equipment items and assemblies
referred to in Article 12(2), in respect of which the
procedures referred to in paragraphs 1 and 2 of this Article have not been
applied and the use of which is in the interests of experimentation.

ê 97/23/EC
(adapted)

4. Records and correspondence relating to
conformity assessment shall be drawn up in the official language(s) of the Community
Ö Union Õ which may be
determined in
accordance with the Treaty by the Member State where the body
responsible for carrying out these procedures is established, or in a language
accepted by that body.

ê 97/23/EC (adapted)

Article 1115

European approval for materials

1. European approval for materials, as defined in Article 1,
section 2.9, shall be issued at the request of one or more
manufacturers of materials or equipment, by one of the notified bodies referred
to in Article 1220
specifically designated for that task. The notified body shall determine and
perform, or arrange for the performance of, the appropriate inspections and
tests to certify the conformity of the types of material with the corresponding
requirements of this Directive;. iIn the case of materials recognizsed as being safe to use before 29
November 1999, the notified body shall take account of the existing data when
certifying such conformity.

ê 97/23/EC
(adapted)

ð new

2. Before issuing Ö a Õ European
approval for materials, the notified body shall inform Ö notify Õ the Member
States and the Commission by sending them the appropriate information. Within
three months, a Member State or the Commission may refer the matter to the Standing Committee set
up by Article 5 of Directive 83/189/EEC, ð provide comments ï giving its reasons. In that case, the
Committee shall issue an opinion as a matter of urgency.

The notified body shall Ö may Õ issue the
European approval for materials taking into account, where appropriate, the opinion of the Committee
and the comments submitted.

ê 97/23/EC
(adapted)

3. A copy of the
European approval for pressure equipment materials shall be sent to the
Member States, the notified bodies and the Commission.

ê 97/23/EC
(adapted)

4.    Ö When the European
approval for materials satisfies the requirements which it covers and which are
set out in Annex I, Õ tThe Commission
shall publish Ö the
references of that approval. Õ and Ö The
Commission shall Õ keep up to
date a list of Ö such Õ European
approvals for materials
in the Official Journal of the European Communities
Ö Union Õ.

ê 97/23/EC
(adapted)

è1 Corrigendum, OJ L 265, 27.9.1997, p. 110

5. The notified body which issued the
European approval for pressure equipment materials shall withdraw that
approval if it finds that it should not have been è1 issued or if the type ç of materials
is covered by a harmonised standard. It shall immediately inform the other
Member States, the notified bodies and the Commission of any withdrawal of an
approval.

ò new

6.         When a
Member State or the Commission considers that a European approval for materials
whose references have been published in the Official Journal of the European
Union, does not entirely satisfy the essential safety requirements which
it covers and which are set out in Annex I, the Commission
shall decide by implementing acts whether to withdraw the
references of that European approval for materials from the Official
Journal of the European Union.

The implementing
acts referred to in the first subparagraph shall be adopted in accordance with
the examination procedure referred to in Article 39(3).

ê 97/23/EC
(adapted)

ð new

Article 1416

User inspectorates

1. By way of derogation from the provisions
relating to the tasks carried out by the notified bodies, Member States may
authorize in
Ö on Õ their
territory the placing ð making available ï on the market, and the putting into service by users, of
pressure equipment or
assemblies referred to in Article 1 of which conformity with
the essential Ö safety Õ requirements
has been assessed by a user inspectorate designated in accordance with the criteria referred to
in paragraph 87.

ê 97/23/EC
(adapted)

3.2. Pressure equipment and assemblies the conformity of
which has been assessed by a user inspectorate shall not bear the CE marking.

ê 97/23/EC
(adapted)

4.3. The pressure equipment and assemblies referred to in paragraph 1 may be used only in
establishments operated by the group of which the inspectorate is part. The
group shall apply a common safety policy as regards the technical
specifications for the design, manufacture, inspection, maintenance and use of
pressure equipment and
assemblies.

ê 97/23/EC
(adapted)

54. The user inspectorates shall act exclusively for the group of
which they are part.

65. The conformity assessment procedures applicable by user
inspectorates shall be modules A12, C12, F and G, as described Ö set
out Õ in Annex III.

ê 97/23/EC
(adapted)

76. Member States shall inform Ö notify Õ the other
Member States and the Commission which user inspectorates they have authorised,
the tasks for which they have been designated and, for each inspectorate, a
list of the establishments satisfying the provisions of paragraph 43.

87. In designating the user inspectorates, the Member States shall
apply the criteria
listed
Ö requirements
set out Õ in Annex
V Article 25 and
ensure that the group of which the inspectorate is part applies the criteria
referred to in the second sentence of paragraph 43.

ê 97/23/EC

9. A Member State
that has authorized a user inspectorate shall withdraw that authorization if it
finds that the user inspectorate no longer meets the criteria referred to in
paragraph 8. It shall inform the other Member States and the Commission
thereof.

10. The effects of
this Article shall be monitored by the Commission and evaluated three years
after the date specified in Article 20 (3). To this end, Member States shall
forward to the Commission any useful information on the implementation of
this Article. If necessary the evaluation shall be accompanied by a proposal
for amendment of the Directive.

ò new

Article 17 [Article
R10 of Decision No 768/2008/EC]

EU declaration of conformity

1. The EU
declaration of conformity shall state that the fulfilment of essential safety requirements
set out in Annex I has been demonstrated.

2. The EU declaration
of conformity shall have the model structure set out in Annex III and shall
contain the elements specified in the relevant conformity assessment procedures
set out in Annex II and shall be continuously updated. It shall be translated
into the language or languages required by the Member State in whose market the
pressure equipment is placed or made available on the market.

3. Where pressure
equipment is subject to more than one Union act requiring an EU declaration of
conformity, a single EU declaration of conformity shall be drawn up in respect
of all such Union acts. That declaration shall contain the identification of
the acts concerned including the publication references.

4. By drawing up
the EU declaration of conformity, the manufacturer shall assume responsibility
for the compliance of the pressure equipment with the requirements laid down in
this Directive.

Article 18 [Article
R11 of Decision No 768/2008/EC]

General principles of the CE marking

The CE marking
shall be subject to the general principles set out in Article 30 of Regulation
(EC) No 765/2008.

ê 97/23/EC
(adapted)

Article 1519 [Article R12 of Decision No
768/2008/EC]

Ö Rules
and conditions for affixing the Õ CE
marking

ê 97/23/EC

1. The CE marking
consists of the initials «CE» in accordance with the model in Annex VI.

The CE marking
shall be accompanied by the identification number, as referred to in Article 12
(1), of the notified body involved at the production control phase.

ê 97/23/EC
(adapted)

ð new

2.1. The CE marking shall be affixed in a visible, easily legible and indelible fashion
Ö visibly,
legibly and indelibly Õ to Ö any of
the following: Õ

(a) each item of pressure equipment referred to in Article 34(1), or

(b) assembly referred to in Article 34(2).

which is
Ö The item
or assembly referred to in points (a) and (b) of the first subparagraph shall
be Õ complete or is Ö shall
be Õ in a state
permitting final assessment as described in section point 3.2 of Annex I ð , or to its data plate. Where the
affixing of the CE marking is not possible or not warranted on account of the
nature of the equipment or assembly, it shall be affixed to the packaging and
to the accompanying documents ï.

3.2.      It is not necessary for the CE marking to be affixed to each
individual item of pressure equipment making up an assembly as referred to in Article
3 (2). Individual items of pressure equipment already bearing
the CE marking when incorporated into the assembly shall continue to bear that
marking.

ê 97/23/EC

4. Where the
pressure equipment or assembly is subject to other Directives covering other
aspects which provide for the affixing of the CE marking, the latter shall
indicate that the pressure equipment or assembly in question is also presumed
to conform to the provisions of those other Directives.

However, should
one or more of those Directives allow the manufacturer, during a transitional
period, to choose which arrangements to apply, the CE marking shall indicate
conformity only with the Directives applied by the manufacturer. In this case,
the particulars of the said Directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or
instructions required by the Directives and accompanying the pressure equipment
or assembly.

5. The affixing of
markings on pressure equipment or assemblies which are likely to mislead third
parties as to the meaning or form of the CE marking shall be prohibited. Any
other marking may be affixed to pressure equipment or assemblies provided that
the visibility and legibility of the CE marking is not thereby reduced.

ò new

3. The CE marking
shall be affixed before the item of pressure equipment or the assembly is
placed on the market.

4. The CE marking
shall be followed by the identification number of the notified body, where that
body is involved in the production control phase.

The
identification number of the notified body shall be affixed by the body itself
or, under its instructions, by the manufacturer or his authorised
representative.

5. The CE marking
and, where applicable, the identification number referred to in paragraph 4 may
be followed by any other mark indicating a special risk or use.

CHAPTER 4

NOTIFICATION
OF CONFORMITY ASSESSMENT BODIES

ê 97/23/EC

Article 12

Notified bodies

1.         Member
States shall notify the Commission and the other Member States of the bodies
which they have appointed to carry out the
procedures referred to in Article 10 and Article 11, together with the specific
tasks which those bodies have been appointed to carry out and the
identification numbers assigned to them beforehand by the Commission.

The Commission
shall publish in the Official
Journal of the European Communities a list of the notified bodies, with their
identification numbers and the tasks for which they have been notified. The
Commission shall ensure that this list is kept up to date.

2.         Member States shall apply the criteria set out in
Annex IV for the designation of bodies. Bodies meeting the criteria laid down
in the relevant harmonized standards shall be presumed to fulfil the
corresponding criteria in Annex IV.

3.         A
Member State which has notified a body must
withdraw such notification if it finds that the body no longer meets the
criteria referred to in paragraph 2.

It shall forthwith
inform the other Member States and the Commission of any such withdrawal of a
notification.

Article 13

Recognized
third-party organizations

1. Member States
shall notify the Commission and the other Member States of the third-party
organizations which they have recognized for the purposes of the tasks referred
to in Annex I, sections 3.2.2 and 3.1.3.

The Commission
shall publish in the Official
Journal of the European Communities a list of the recognized organizations with the
tasks for which they have been recognized. The Commission shall ensure that
this list is kept up to date.

2. Member States
shall apply the criteria set out in Annex IV for the recognition of
organizations. Organizations meeting the criteria laid down in the relevant
harmonized standards shall be presumed to fulfil the corresponding criteria in
Annex IV.

3. A Member State
which has recognized an organization must withdraw such recognition if it
finds that the organization no longer meets the criteria referred to in
paragraph 2.

It shall forthwith
inform the other Member States and the Commission of any such withdrawal of a
recognition.

ò new

Article 20 [Article
R13 of Decision No 768/2008/EC]

Notification

Member States
shall notify the Commission and the other Member States of the notified bodies and
the user inspectorates authorised to carry out third-party conformity assessment
tasks in accordance with Article 15, Article 16 or Annex III and of the
third-party organisations they have recognised, for the purposes of the tasks
referred to in points 3.1.2 and 3.1.3 of Annex I.

Article 21 [Article
R14 of Decision No 768/2008/EC]

Notifying authorities

1.         Member
States shall designate a notifying authority that shall be responsible for
setting up and carrying out the necessary procedures for the assessment and
notification of conformity assessment bodies and the monitoring of notified
bodies, recognised third-party organisations and user inspectorates, including
compliance with Article 26.

2.         Member
States may decide that the assessment and monitoring referred to in paragraph 1
shall be carried out by a national accreditation body within the meaning of and
in accordance with Regulation (EC) No 765/2008.

3.         Where
the notifying authority delegates or otherwise entrusts the assessment,
notification or monitoring referred to in paragraph 1 to a body which is not a
governmental entity, that body shall be a legal entity and shall comply mutatis
mutandis with the requirements laid down in Article 22(1) to (6). In
addition it shall have arrangements to cover liabilities arising out of its
activities.

4.         The
notifying authority shall take full responsibility for the tasks performed by
the body referred to in paragraph 3.

Article 22 [Article
R15 of Decision No 768/2008/EC]

Requirements relating to notifying authorities

1.         A
notifying authority shall be established in such a way that no conflict of
interest with conformity assessment bodies occurs.

2.         A
notifying authority shall be organised and operated so as to safeguard the
objectivity and impartiality of its activities.

3.         A
notifying authority shall be organised in such a way that each decision
relating to notification of a conformity assessment body is taken by competent
persons different from those who carried out the assessment.

4.         A
notifying authority shall not offer or provide any activities that conformity
assessment bodies perform or consultancy services on a commercial or
competitive basis.

5.         A
notifying authority shall safeguard the confidentiality of the information it
obtains.

6.         A
notifying authority shall have a sufficient number of competent personnel at
its disposal for the proper performance of its tasks.

Article 23 [Article
R16 of Decision No 768/2008/EC]

Information obligation on notifying authorities

Member States
shall inform the Commission of their procedures for the assessment and
notification of conformity assessment bodies and the monitoring of notified
bodies, recognised third-party organisations and user inspectorates, and of any
changes thereto.

The Commission shall make that information publicly
available.

Article 24 [Article
R17 of Decision No 768/2008/EC]

Requirements relating to notified bodies and recognised third-party
organisations

1.         For
the purposes of notification, a notified body or recognised third party
organisation shall meet the requirements laid down in paragraphs 2 to 11.

2.         A
conformity assessment body shall be established under national law and have
legal personality.

3.         A
conformity assessment body shall be a third-party body independent of the
organisation or the pressure equipment it assesses.

A body belonging
to a business association or professional federation representing undertakings
involved in the design, manufacturing, provision, assembly, use or maintenance
of pressure equipment which it assesses, may, on condition that its
independence and the absence of any conflict of interest are demonstrated, be
considered such a body.

4.         A
conformity assessment body, its top level management and the personnel
responsible for carrying out the conformity assessment tasks shall not be the
designer, manufacturer, supplier, installer, purchaser, owner, user or
maintainer of the pressure equipment which they assess, nor the representative
of any of those parties. This shall not preclude the use of assessed pressure
equipment that are necessary for the operations of the conformity assessment
body or the use of such equipment for personal purposes.

A conformity
assessment body, its top level management and the personnel responsible for
carrying out the conformity assessment tasks shall not be directly involved in
the design, manufacture or construction, the marketing, installation, use or
maintenance of that pressure equipment, or represent the parties engaged in
those activities. They shall not engage in any activity that may conflict with
their independence of judgement or integrity in relation to conformity assessment
activities for which they are notified. This shall in particular apply to
consultancy services.

Conformity
assessment bodies shall ensure that the activities of their subsidiaries or
subcontractors do not affect the confidentiality, objectivity or impartiality
of their conformity assessment activities.

5.         Conformity
assessment bodies and their personnel shall carry out the conformity assessment
activities with the highest degree of professional integrity and the requisite
technical competence in the specific field and shall be free from all pressures
and inducements, particularly financial, which might influence their judgement
or the results of their conformity assessment activities, especially as regards
persons or groups of persons with an interest in the results of those
activities.

6.         A
conformity assessment body shall be capable of carrying out all the conformity
assessment tasks assigned to it by Article 15, Annex III or points 3.1.2 and
3.1.3 of Annex I and in relation to which it has been notified, whether those
tasks are carried out by the conformity assessment body itself or on its behalf
and under its responsibility.

At all times and
for each conformity assessment procedure and each kind or category of pressure
equipment in relation to which it has been notified, a conformity assessment
body shall have at its disposal the necessary:

(a)     personnel
with technical knowledge and sufficient and appropriate experience to perform
the conformity assessment tasks;

(b)     descriptions
of procedures in accordance with which conformity assessment is carried out,
ensuring the transparency and the ability of reproduction of those procedures.
It shall have appropriate policies and procedures in place that distinguish
between tasks it carries out as a conformity assessement body and other
activities;

(c)     procedures
for the performance of activities which take due account of the size of an
undertaking, the sector in which it operates, its structure, the degree of
complexity of the product technology in question and the mass or serial nature
of the production process.

It shall have the
means necessary to perform the technical and administrative tasks connected
with the conformity assessment activities in an appropriate manner and shall
have access to all necessary equipment or facilities.

7.         The
personnel responsible for carrying out conformity assessment activities shall
have the following:

(a)     sound
technical and vocational training covering all the conformity assessment
activities in relation to which the conformity assessment body has been
notified;

(b)     satisfactory
knowledge of the requirements of the assessments they carry out and adequate
authority to carry out those assessments;

(c)     appropriate
knowledge and understanding of the essential safety requirements set out in
Annex I, of the applicable harmonised standards and of the relevant provisions
of Union harmonisation
legislation and of national legislation;

(d)     the ability
to draw up certificates, records and reports demonstrating that assessments
have been carried out.

8.         The
impartiality of the conformity assessment bodies, their top level management
and of the assessment personnel shall be guaranteed.

The remuneration
of the top level management and assessment personnel of a conformity assessment
body shall not depend on the number of assessments carried out or on the
results of those assessments.

9.         Conformity
assessment bodies shall take out liability insurance unless liability is
assumed by the State in accordance with national law, or the Member State
itself is directly responsible for the conformity assessment.

10.       The
personnel of a conformity assessment body shall observe professional secrecy
with regard to all information obtained in carrying out their tasks under
Article 15, Annex III or under points 3.1.2 and 3.1.3 of Annex I or any
provision of national law giving effect to them, except in relation to the
competent authorities of the Member State in which its activities are carried
out. Proprietary rights shall be protected.

11.       Conformity
assessment bodies shall participate in, or ensure that their assessment
personnel are informed of, the relevant standardisation activities and the
activities of the notified body coordination group established under the
relevant Union harmonisation
legislation and shall apply as general guidance the administrative decisions
and documents produced as a result of the work of that group.

Article 25

Requirements relating to user inspectorates

1.         For
the purposes of notification, a user inspectorate shall meet the requirements
laid down in paragraphs 2 to 11.

2.         A user
inspectorate shall be established under national law and have legal
personality.

3.         A user
inspectorate shall be organisationally identifiable and have reporting methods
within the group of which it is part which ensure and demonstrate its
impartiality.

4.         A user
inspectorate, its top level management and the personnel responsible for
carrying out the conformity assessment tasks shall not be the designer,
manufacturer, supplier, installer, purchaser, owner, user or maintainer of the
pressure equipment which they assess, nor the authorised representative of any
of those parties. This shall not preclude the use of assessed pressure
equipment that is necessary for the operations of the user inspectorate or the
use of such equipment for personal purposes.

A user
inspectorate, its top level management and the personnel responsible for
carrying out the conformity assessment tasks shall not be directly involved in
the design, manufacture or construction, the marketing, installation, use or
maintenance of that pressure equipment, or represent the parties engaged in
those activities. They shall not engage in any activity that may conflict with their
independence of judgement or integrity in relation to conformity assessment
activities for which they are notified. This shall in particular apply to
consultancy services.

5.         User
inspectorates and their personnel shall carry out the conformity assessment
activities with the highest degree of professional integrity and the requisite
technical competence in the specific field and shall be free from all pressures
and inducements, particularly financial, which might influence their judgement
or the results of their conformity assessment activities, especially as regards
persons or groups of persons with an interest in the results of those
activities.

6.         A user
inspectorate shall be capable of carrying out all the conformity assessment
tasks assigned to it by Article 16 and in relation to which it has been
notified, whether those tasks are carried out by the user inspectorate itself
or on its behalf and under its responsibility.

At all times and
for each conformity assessment procedure and each kind or category of pressure
equipment in relation to which it has been notified, the user inspectorate shall
have at its disposal the necessary:

(a)     personnel
with technical knowledge and sufficient and appropriate experience to perform
the conformity assessment tasks;

(b)     descriptions
of procedures in accordance with which conformity assessment is carried out,
ensuring the transparency and the ability of reproduction of those procedures.
It shall have appropriate policies and procedures in place that distinguish
between tasks it carries out as a user inspectorate and other activities;

(c)     procedures
for the performance of activities which take due account of the size of an
undertaking, the sector in which it operates, its structure, the degree of
complexity of the product technology in question and the mass or serial nature
of the production process.

It shall have the
means necessary to perform the technical and administrative tasks connected
with the conformity assessment activities in an appropriate manner and shall
have access to all necessary equipment or facilities.

7.         The
personnel responsible for carrying out conformity assessment activities shall
have the following:

(a)     sound
technical and vocational training covering all the conformity assessment
activities in relation to which the conformity assessment body has been
notified;

(b)     satisfactory
knowledge of the requirements of the assessments they carry out and adequate
authority to carry out those assessments;

(c)     appropriate
knowledge and understanding of the essential safety requirements set out in
Annex I, of the applicable harmonised standards and of the relevant provisions
of Union harmonisation
legislation and of national legislation;

(d)     the ability
to draw up certificates, records and reports demonstrating that assessments
have been carried out.

8.         The
impartiality of the user inspectorates, their top level management and of the
assessment personnel shall be guaranteed. User inspectorates must not engage in
any activities that might conflict with its independence of judgement and
integrity in relation to its inspection activities.

The remuneration
of the top level management and assessment personnel of a user inspectorate shall
not depend on the number of assessments carried out or on the results of those
assessments.

9.         User
inspectorates shall take out liability insurance unless liability is assumed by
the group of which they are part.

10.       The
personnel of user inspectorates shall observe professional secrecy with regard
to all information obtained in carrying out their tasks under Article 16 or any
provision of national law giving effect to them, except in relation to the
competent authorities of the Member State in which its activities are carried
out. Proprietary rights shall be protected.

11.       User
inspectorates shall participate in, or ensure that their assessment personnel
are informed of, the relevant standardisation activities and the activities of
the notified body coordination group established under the relevant Union harmonisation
legislation and apply as general guidance the administrative decisions and
documents produced as a result of the work of that group.

Article 26 [Article R18 of Decision No 768/2008/EC]

Presumption of conformity

Where a
conformity assessment body demonstrates its conformity with the criteria laid
down in the relevant harmonised standards or parts thereof the references of
which have been published in the Official Journal of the European Union it
shall be presumed to comply with the requirements set out in Articles 24 or 25
in so far as the applicable harmonised standards cover those requirements.

Article 27 [Article R20 of Decision No 768/2008/EC]

Subsidiaries of and subcontracting by notified bodies and recognised
third-party organisations

1.         Where
a notified body or a recognised third-party organisation subcontracts specific
tasks connected with conformity assessment or has recourse to a subsidiary, it
shall ensure that the subcontractor or the subsidiary meets the requirements
set out in Article 24 and shall inform the notifying authority accordingly.

2.         Notified
bodies and recognised third-party organisations shall take full responsibility
for the tasks performed by subcontractors or subsidiaries wherever these are
established.

3.         Activities
may be subcontracted or carried out by a subsidiary only with the agreement of
the client.

4.         Notified
bodies and recognised third-party organisations shall keep at the disposal of
the notifying authority the relevant documents concerning the assessment of the
qualifications of the subcontractor or the subsidiary and the work carried out
by them under Article 15, Annex III or points 3.1.2 and 3.1.3 of Annex I.

Article 28 [Article
R22 of Decision No 768/2008/EC]

Application for notification

1.         A
conformity assessment body shall submit an application for notification to the
notifying authority of the Member State in which it is established.

2.         That
application shall be accompanied by a description of the conformity assessment
activities, the conformity assessment module or modules and the pressure
equipment for which that body claims to be competent, as well as by an
accreditation certificate, where one exists, issued by a national accreditation
body attesting that the conformity assessment body fulfils the requirements
laid down in Article 24 or 25.

3.         Where
the conformity assessment body concerned cannot provide an accreditation
certificate, it shall provide the notifying authority with all the documentary
evidence necessary for the verification, recognition and regular monitoring of
its compliance with the requirements laid down in Article 24 or 25.

Article 29 [Article
R23 of Decision No 768/2008/EC]

Notification procedure

1.         Notifying
authorities may notify only conformity assessment bodies which have satisfied
the requirements laid down in Article 24 or 25.

2.         They
shall notify the Commission and the other Member States using the electronic
notification tool developed and managed by the Commission.

3.         The
notification shall include full details of the conformity assessment activities,
the conformity assessment module or modules and the pressure equipment concerned
and the relevant attestation of competence.

4.         Where
a notification is not based on an accreditation certificate as referred to in
Article 28(2), the notifying authority shall provide the Commission and the
other Member States with documentary evidence which attests to the conformity
assessment body's competence and the arrangements in place to ensure that that
body will be monitored regularly and will continue to satisfy the requirements
laid down in Article 24 or 25.

5.         The
body concerned may perform the activities of a notified body, a recognised
third-party organisation or a user inspectorate only where no objections are
raised by the Commission or the other Member States within two weeks of a
notification where an accreditation certificate is used or within two months of
a notification where accreditation is not used.

Only such a body
shall be considered a notified body, a recognised third-party organisation or a
user inspectorate for the purposes of this Directive.

6.         The
Commission and the other Member States shall be notified of any subsequent
relevant changes to the notification.

Article 30 [Article
R24 of Decision No 768/2008/EC]

Identification numbers and lists of notified bodies

1.         The
Commission shall assign an identification number to a notified body.

It shall assign a
single such number even where the body is notified under several Union acts.

2.         The
Commission shall make publicly available the list of the notified bodies under
this Directive, including the identification numbers that have been allocated
to them and the activities for which they have been notified.

The Commission
shall ensure that that list is kept up to date.

Article 31

Lists of recognised third-party organisations and user inspectorates

The Commission
shall make publicly available the list of the recognised third-party
organisations and of the user inspectorates under this Directive and the tasks
for which they have been recognised.

The Commission
shall ensure that that list is kept up to date.

Article 32 [Article
R25 of Decision No 768/2008/EC]

Changes to notifications

1.         Where
a notifying authority has ascertained or has been informed that a notified body
or a recognised third-party organisation no longer meets the requirements laid
down in Article 24 or that it is failing to fulfil its obligations, the
notifying authority shall, as appropriate, restrict, suspend or withdraw the notification,
depending on the seriousness of the failure to meet those requirements or
fulfil those obligations. It shall immediately inform the Commission and the
other Member States accordingly.

Where a notifying
authority has ascertained or has been informed that a user inspectorate no
longer meets the requirements laid down in Article 25, or that it is failing to
fulfil its obligations, the notifying authority shall as appropriate, restrict,
suspend or withdraw the notification, depending on the seriousness of the
failure to meet those requirements or fulfil those obligations. It shall
immediately inform the Commission and the other Member States accordingly.

2.         In the
event of restriction, suspension or withdrawal of notification, or where the
notified body, the recognised third-party organisation or the user inspectorate
has ceased its activity, the notifying Member State shall take appropriate
steps to ensure that the files of that body are either processed by another
notified body, recognised third-party organisation or user inspectorate, or
kept available for the responsible notifying and market surveillance
authorities at their request.

Article 33 [Article
R26 of Decision No 768/2008/EC]

Challenge of the competence of notified bodies, recognised third party
organisations and user inspectorates

1.         The
Commission shall investigate all cases where it doubts, or doubt is brought to
its attention regarding, the competence of a notified body, a recognised
third-party organisation or a user inspectorate, or the continued fulfilment by
a notified body, a recognised third-party organisation or a user inspectorate
of the requirements and responsibilities to which it is subject.

2.         The
notifying Member State shall provide the Commission, on request, with all
information relating to the basis for the notification or the maintenance of
the competence of the body concerned.

3.         The
Commission shall ensure that all sensitive information obtained in the course
of its investigations is treated confidentially.

4.         Where
the Commission ascertains that a notified body, a recognised third-party organisation
or a user inspectorate does not meet or no longer meets the requirements for
its notification, it shall adopt an implementing act requesting the notifying
Member State to take the necessary corrective measures, including withdrawal of
notification if necessary.

The implementing
act referred to in the first subparagraph shall be adopted in accordance with
the advisory procedure referred to in Article 39(2).

Article 34 [Article
R27 of Decision No 768/2008/EC]

Operational obligations of notified bodies, user inspectorates and recognised third party
organisations

1.         Notified
bodies, user inspectorates and recognised third-party organisations shall carry
out conformity assessments in accordance with the conformity assessment tasks provided
for in Article 15, Article 16, Annex III or in points 3.1.2 and 3.1.3 of Annex
I.

2.         Conformity
assessments shall be carried out in a proportionate manner, avoiding
unnecessary burdens for economic operators.

Conformity
assessment bodies shall perform their activities taking due account of the size
of an undertaking, the sector in which it operates, its structure, the degree
of complexity of the pressure equipment or assembly technology in question and
the mass or serial nature of the production process.

In so doing they
shall nevertheless respect the degree of rigour and the level of protection
required for the compliance of the pressure equipment with the provisions of
this Directive.

3.         Where
a conformity assessment body finds that essential safety requirements set out in
Annex I or corresponding harmonised standards have not been met by a
manufacturer, it shall require that manufacturer to take appropriate corrective
measures and shall not issue a conformity certificate.

4.         Where,
in the course of the monitoring of conformity following the issue of a
certificate, a conformity assessment body finds that pressure equipment no
longer complies, it shall require the manufacturer to take appropriate
corrective measures and shall suspend or withdraw the certificate if necessary.

5.         Where
corrective measures are not taken or do not have the required effect, the conformity
assessment body shall restrict, suspend or withdraw any certificates, as
appropriate.

Article 35

Appeal against decisions of notified bodies, recognised third party
organisations and user inspectorates

Member States
shall ensure that an appeal procedure against decisions of notified bodies,
recognised third-party organisations or user inspectorates is available.

Article 36 [Article
R28 of Decision No 768/2008/EC]

Information obligation on notified bodies, recognised third party
organisations and user inspectorates

1.         Notified
bodies, recognised third-party organisations and user inspectorates shall
inform the notifying authority of the following:

(a)     any refusal,
restriction, suspension or withdrawal of a certificate;

(b)     any circumstances
affecting the scope of and conditions for notification;

(c)     any request
for information which they have received from market surveillance authorities
regarding conformity assessment activities;

(d)     on request,
conformity assessment activities performed within the scope of their
notification and any other activity performed, including cross-border
activities and subcontracting.

2.         Notified
bodies, recognised third-party organisations and user inspectorates shall
provide the other bodies notified under this Directive carrying out similar
conformity assessment activities covering the same pressure equipment with
relevant information on issues relating to negative and, on request, positive
conformity assessment results.

Article 37 [Article
R29 of Decision No 768/2008/EC]

Exchange of experience

The Commission
shall provide for the organisation of exchange of experience between the Member
States' national authorities responsible for notification policy.

Article 38 [Article
R30 of Decision No 768/2008/EC]

Coordination of notified bodies, recognized third-party
organisations and user inspectorates

The Commission
shall ensure that appropriate coordination and cooperation between the
conformity assessment bodies notified under this Directive are put in place and
properly operated in the form of a sectoral group or groups of conformity assessment bodies.

Member States
shall ensure that the conformity assessment bodies notified by them participate
in the work of that or those group or groups, directly or by means of
designated representatives.

ê 97/23/EC

Article 8

Safeguard clause

1. Where a Member
State ascertains that pressure equipment or assemblies referred to in Article
1, bearing the CE marking and used in accordance with their intended use are
liable to endanger the safety of persons and, where appropriate, domestic
animals or property, it shall take all appropriate measures to withdraw such
equipment or assemblies from the market, prohibit the placing on the market,
putting into service or use thereof, or
restrict free movement thereof.

The Member State
shall immediately inform the Commission of any such measure, indicating the
reasons for its decision and, in particular, whether non-conformity is due to:

(a)        failure
to satisfy the essential requirements
referred to in Article 3;

(b)        incorrect
application of the standards referred to in Article 5 (2);

(c)        shortcomings
in the standards referred to in Article 5 (2);

(d)        shortcomings
in the European approval of pressure equipment materials as referred to in Article 11.

2. The Commission
shall enter into consultation with the parties concerned without delay. Where
the Commission considers, after this consultation, that the measure is
justified, it shall immediately so inform the Member State which took the
initiative and the other Member States.

Where the
Commission considers, after this consultation, that the measure is unjustified,
it shall immediately so inform the Member State which took the initiative and
the manufacturer, or his authorized representative established within the
Community. Where the decision referred to in paragraph 1 is based on a
shortcoming in the standards or in European approvals for materials and where
the Member State at the origin of the decision maintains its position the Commission shall immediately inform the
Committee referred to in Article 6 in order to initiate the procedure referred
to in the first paragraph of Article 6.

3. Where pressure
equipment or an assembly which does not comply bears the CE marking, the competent
Member State shall take appropriate action against the person(s) having affixed
the CE marking and shall so inform the Commission and the other Member Sates.

4. The Commission
shall ensure that the Member Sates are kept informed of the progress and outcome
of this procedure.

Article 16

Unduly affixed CE
marking

Without prejudice
to Article 8:

(a)        where
a Member State establishes that the CE marking has been affixed unduly, the
manufacturer, or his authorized representative established within the Community, shall be obliged to make the product
conform as regards the provisions concerning the CE marking and to end the
infringement under the conditions imposed by the Member State;

(b)        should
non-conformity persist, the Member State must take all appropriate measures to restrict or prohibit the
placing on the market of the product in question or to ensure that it is
withdrawn from the market in accordance with the procedures laid down in
Article 8.

Article 17

Member States
shall take appropriate measures in order to encourage the authorities
responsible for implementing this Directive to cooperate with each other and
provide each other and the Commission with information in order to assist the
functioning of this Directive.

Article 18

Decisions
entailing refusal or restriction

Any decision taken
pursuant to this Directive which restricts the placing on the market and the
putting into service or requires the withdrawal from the market of pressure
equipment or assemblies shall state the exact grounds on which it is based.
Such decision shall be notified forthwith to the party concerned, who shall at
the same time be informed of the legal remedies available to him under the laws
in force in the Member State concerned and of the time limits to which such remedies are subject.

ê 97/23/EC
(adapted)

CHAPTER
5

Ö COMMITTEE
PROCEDURE AND DELEGATED ACTS Õ

Article 7 39

Committee on Pressure Equipment Ö procedure Õ

ê 1882/2003
Art. 1 and Annex I.13 (adapted)

ð new

21. The Commission shall be assisted by a standing committee (hereinafter
referred to as «the Committee») Ö the
Committee on Pressure Equipment established by Directive 97/23/EC Õ. ð That committee shall be a committee
within the meaning of Regulation (EU) No 182/2011. ï

The Committee
shall draw up its rules of procedure.

3 2. Where reference is made to this paragraph, Article
4, Articles 3 and 7
of Decision 1999/468/EC[44]
ð of Regulation (EU) No 182/2011 ï shall apply, having
regard to the provisions of Article 8 thereof.

ò new

3. Where
reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011
shall apply.

Where the opinion
of the committee is to be obtained by written procedure, that procedure shall
be terminated without result when, within the time-limit for delivery of the
opinion, the chair of the committee so decides or a simple majority of committee
members so request.

ê 97/23/EC

4. The Committee
may furthermore examine any other matter relating to the implementation and practical application of this
Directive and raised by its chairman either on his own initiative or at the request
of a Member State.

ò new

Article 40

Amendments of Annexes

The Commission
shall be empowered to adopt delegated acts in accordance with Article 41
concerning the reclassification of pressure equipment when it has any of the
following considerations:

ê 97/23/EC

1. The Commission
may take any appropriate measure to implement the following provisions:

Where a Member
State considers that, for very serious safety reasons,

ê 97/23/EC
(adapted)

(a)     an item or family of pressure equipment referred to in Article 34(3) should be subject to the
requirements of Article 34(1),; or

(b)     an assembly or family of assemblies referred to in Article 34(3) should be subject to the
requirements of Article 34(2),; or

ê 97/23/EC

(c)     an item or family of pressure equipment should be classified,
by way of derogation from the requirements of Annex II, in another category,.

it shall submit a
duly substantiated request to the Commission and ask it to take the necessary
measures. Those measures shall be adopted in accordance with the procedure
laid down in paragraph 3 .

ò new

Article 41

Exercise of the delegation

1.         The
power to adopt delegated acts is conferred on the Commission subject to the
conditions laid down in this Article.

2.         The
delegation of power referred to in Article 40 shall be conferred for an
indeterminate period of time from 1 June 2015.

3.         The
delegation of powers referred to in Article 40 may be revoked at any time by
the European Parliament or by the Council. A decision to revoke shall put an
end to the delegation of the power specified in that decision. It shall take
effect the day following the publication of the decision in the Official
Journal of the European Union or at a later date specified therein.
It shall not affect the validity of any delegated acts already in force.

4.         As
soon as it adopts a delegated act, the Commission shall notify it
simultaneously to the European Parliament and to the Council.

5.         A
delegated act adopted pursuant to Article 40 shall enter into force only if no
objection has been expressed either by the European Parliament or the Council
within a period of two months of notification of that act to the European
Parliament and the Council or if, before the expiry of that period, the European Parliament and the
Council have both informed the Commission that they will not object. That period shall be extended by two
months at the initiative of the European Parliament or of the Council.

CHAPTER 6

TRANSITIONAL AND
FINAL PROVISIONS

Article 42

Penalties

Member States
shall lay down rules on penalties applicable to infringements by economic
operators of the national provisions adopted pursuant to this Directive and
shall take all measures necessary to ensure that they are implemented. Such
rules may include criminal penalties for serious infringements.

The penalties referred
to in the first subparagraph must be effective, proportionate and dissuasive.

ê 97/23/EC
(adapted)

ð new

Article
43

Ö Transitional
provisions Õ

31. Member States must permit Ö shall not
impede Õ the placing on the market ð putting into service ï of pressure equipment and assemblies which comply with the
regulations in force in their territory at the date of application of this
Directive 97/23/EC ð and were placed on the market ï until 29 May 2002, and permit such
equipment and assemblies to be put into service beyond that date.

ò new

2.         Member
States shall not impede the making available on the market and/or the putting
into service of pressure equipment covered by Directive 97/23/EC which are in
conformity with that Directive and which were placed on the market before 1
June 2015.

3.         Certificates
issued under Directive 97/23/EC shall be valid under this Directive.

ê 97/23/EC
(adapted)

Article 2044

Transposition
and transitional provisions

1. Before 29 May 1999 Member States
shall adopt and publish Ö by 1
March 2015 at the latest, Õ the laws,
regulations and administrative provisions necessary to comply with this Directive
Ö Articles 2(15)
to (31), 6, 7, 8, 9, 10, 11, 12, 17, 18, 19(3) to (5), 20, 21, 22, 23, 24, 25,
26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 42, 43 and Annexes III and
IV Õ. They shall forthwith
inform
Ö communicate
to Õ the Commission
thereof
Ö the text
of those measures Õ .

Member States Ö They Õ shall apply such Ö those
measures Õ provisions as
from 29 November
1999 Ö 1 June
2015 Õ .

When Member States adopt these Ö those Õ measures referred to in the
first subparagraph, they shall contain a reference to
this Directive or shall
be accompanied by such reference on the occasion of their official publication.
The methods of
making such reference shall be laid down by Member States.
Ö They shall also include a statement that
references in existing laws, regulations and administrative provisions to
Directive 97/23/EC shall be construed as references to this Directive. Member
States shall determine how such reference is to be made and how that statement
is to be formulated. Õ

2. Member States shall communicate to the
Commission the texts of the Ö main Õ provisions of
national law which they adopt in the field governed by this Directive.

Article 19 45

Repeal

Article 22 of Directive 76/767/EEC shall cease to
apply as from 29 November 1999 in respect of pressure equipment and assemblies
covered by this Directive.

ê

Directive 97/23/EC, as amended by the acts listed in
Annex V, Part A, is repealed with effect from 1 June 2015, without prejudice to
the obligations of the Member States relating to the time‑limits for
transposition into national law and application of that Directive, set out in Part
B of Annex V.

References to the repealed Directive shall
be construed as references to this Directive and shall be read in accordance
with the correlation table in Annex VI.

Article 46

Entry into
force

This Directive shall enter into force on the
twentieth day following that of its publication in the Official Journal of
the European Union.

Articles 1, 2(1) to (14), 3, 4, 5, 13, 14,
15, 16, 19(1) and (2), 39, 40 and 41 and Annexes I and II shall apply from 1
June 2015.

ê 97/23/EC

Article
47

Addressees of the Directive

This
Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament                       For
the Council

The
President                                                 The President

ê 97/23/EC

ANNEX I

ESSENTIAL SAFETY REQUIREMENTS

PRELIMINARY
OBSERVATIONS

ê 97/23/EC
(adapted)

1. The obligations arising from the
essential Ö safety Õ requirements
listed in this Annex for pressure equipment also apply to assemblies where the
corresponding hazard
Ö risk Õ exists.

2. The essential Ö safety Õ requirements
laid down in the
Ö this Õ Directive are
compulsory. The obligations laid down Ö following
from Õ in these
Ö those Õ essential Ö safety Õ requirements
apply only if the corresponding hazard Ö risk Õ exists for the
pressure equipment in question when it is used under conditions which are
reasonably foreseeable by the manufacturer.

3. The manufacturer is under an obligation
to analyse the hazards
Ö risks Õ in order to
identify those which apply to his equipment on account of pressure; he must Ö shall Õ then design
and construct it taking account of his analysis.

4. The essential Ö safety Õ requirements
are to be interpreted and applied in such a way as to take account of the state
of the art and current practice at the time of design and manufacture as well
as of technical and economic considerations which are consistent with a high
degree of health and safety protection.

1. GENERAL

1.1. Pressure equipment must Ö shall Õ be designed,
manufactured and checked, and if applicable equipped and installed, in such a
way as to ensure its safety when put into service in accordance with the
manufacturer's instructions, or in reasonably foreseeable conditions.

1.2. In choosing the most appropriate
solutions, the manufacturer must Ö shall Õ apply the
principles set out below in the following order:

– 
eliminate or reduce hazards Ö risks Õ as far as is
reasonably practicable,;

– 
apply appropriate protection measures against hazards
Ö risks Õ which cannot
be eliminated,;

– 
where appropriate, inform users of residual hazards
Ö risks Õ and indicate
whether it is necessary to take appropriate special measures to reduce the
risks at the time of installation and/or use.

1.3. Where the potential for misuse is
known or can be clearly foreseen, the pressure equipment must Ö shall Õ be designed to
prevent danger from such misuse or, if that is not possible, adequate warning
given that the pressure equipment must Ö shall Õ not be used in
that way.

2. DESIGN

2.1. General

The pressure equipment must Ö shall Õ be properly
designed taking all relevant factors into account in order to ensure that the
equipment will be safe throughout its intended life.

The design must Ö shall Õ incorporate
appropriate safety coefficients using comprehensive methods which are known to
incorporate adequate safety margins against all relevant failure modes in a
consistent manner.

2.2. Design for adequate strength

2.2.1. The pressure equipment must Ö shall Õ be designed
for loadings appropriate to its intended use and other reasonably foreseeable
operating conditions. In particular, the following factors must Ö shall Õ be taken into
account:

ê 97/23/EC

– 
internal/external pressure,;

– 
ambient and operational temperatures,;

– 
static pressure and mass of contents in
operating and test conditions,;

– 
traffic, wind, earthquake loading,;

– 
reaction forces and moments which result from
the supports, attachments, piping, etc.,;

– 
corrosion and erosion, fatigue, etc.,;

– 
decomposition of unstable fluids.

ê 97/23/EC
(adapted)

Various loadings which can occur at the
same time must
Ö shall Õ be considered,
taking into account the probability of their simultaneous occurrence.

2.2.2. Design for adequate strength must Ö shall Õ be based on Ö either of
the following Õ:

– 
as a general rule, a calculation method, as
described in 2.2.3, and supplemented if necessary by an experimental design
method as described in 2.2.4,; or

ê 97/23/EC

– 
an experimental design method without
calculation, as described in 2.2.4, when the product of the maximum allowable
pressure PS and the volume V is less than 6000 bar·L or the product PS·DN less
than 3000 bar.

2.2.3. Calculation method

(a) Pressure containment and other
loading aspects

ê 97/23/EC
(adapted)

The allowable stresses for pressure
equipment must
Ö shall Õ be limited
having regard to reasonably foreseeable failure modes under operating
conditions. To this end, safety factors must Ö shall Õ be applied to
eliminate fully any uncertainty arising out of manufacture, actual operational
conditions, stresses, calculation models and the properties and behaviour of
the material.

These calculation methods must Ö shall Õ provide
sufficient safety margins consistent, where applicable, with the requirements
of section
point 7.

ê 97/23/EC

The requirements set out above may be met
by applying one of the following methods, as appropriate, if necessary as a
supplement to or in combination with another method:

– 
design by formula,;

– 
design by analysis,;

– 
design by fracture mechanics;.

(b) Resistance

ê 97/23/EC
(adapted)

Appropriate design calculations must Ö shall Õ be used to
establish the resistance of the pressure equipment concerned.

In particular:

– 
the calculation pressures must Ö shall Õ not be less
than the maximum allowable pressures and take into account static head and
dynamic fluid pressures and the decomposition of unstable fluids. Where a
vessel is separated into individual pressure-containing chambers, the partition
wall must
Ö shall Õ be designed on
the basis of the highest possible chamber pressure relative to the lowest
pressure possible in the adjoining chamber,

– 
the calculation temperatures must Ö shall Õ allow for
appropriate safety margins,

– 
the design must Ö shall Õ take
appropriate account of all possible combinations of temperature and pressure
which might arise under reasonably foreseeable operating conditions for the
equipment,

– 
the maximum stresses and peak stress
concentrations must
Ö shall Õ be kept within
safe limits,

– 
the calculation for pressure containment must Ö shall Õ utilizse the values appropriate to the
properties of the material, based on documented data, having regard to the
provisions set out in section point 4 together with appropriate
safety factors. Material characteristics to be considered, where applicable,
include:

ê 97/23/EC

– 
yield strength, 0,2 % or 1,0 % proof
strength as appropriate at calculation temperature,;

– 
tensile strength,;

– 
time-dependent strength, i.e. creep strength,;

– 
fatigue data,;

– 
Young's modulus (modulus of elasticity),;

– 
appropriate amount of plastic strain,;

ê 97/23/EC
(adapted)

– 
impact strength Ö bending
rupture energy Õ ,;

ê 97/23/EC

– 
fracture toughness,.

ê 97/23/EC (adapted)

– 
appropriate joint factors must Ö shall Õ be applied to
the material properties depending, for example, on the type of non-destructive
testing, the materials joined and the operating conditions envisaged,;

– 
the design must Ö shall Õ take
appropriate account of all reasonably foreseeable degradation mechanisms (e.g.
corrosion, creep, fatigue) commensurate with the intended use of the equipment.
Attention must
Ö shall Õ be drawn, in
the instructions referred to in section point 3.4, to particular features of the
design which are relevant to the life of the equipment, for example:

ê 97/23/EC

– 
for creep: design hours of operation at
specified temperatures,;

– 
for fatigue: design number of cycles at
specified stress levels,;

– 
for corrosion: design corrosion allowance;.

(c) Stability aspects

ê 97/23/EC (adapted)

Where the calculated thickness does not
allow for adequate structural stability, the necessary measures must Ö shall Õ be taken to
remedy the situation taking into account the risks from transport and handling.

ê 97/23/EC

2.2.4. Experimental design method

The design of the equipment may be
validated, in all or in part, by an appropriate test programme carried out on a
sample representative of the equipment or the category of equipment.

ê 97/23/EC (adapted)

The test programme must Ö shall Õ be clearly
defined prior to testing and accepted by the notified body responsible for the
design conformity assessment module, where it exists.

This programme must Ö shall Õ define test
conditions and criteria for acceptance or refusal. The actual values of the
essential dimensions and characteristics of the materials which constitute the
equipment tested shall be measured before the test.

Where appropriate, during tests, it must Ö shall Õ be possible to
observe the critical zones of the pressure equipment with adequate
instrumentation capable of registering strains and stresses with sufficient
precision.

The test programme must Ö shall Õ include:

ê 97/23/EC

(a)        A pressure strength test, the
purpose of which is to check that, at a pressure with a defined safety margin
in relation to the maximum allowable pressure, the equipment does not exhibit
significant leaks or deformation exceeding a determined threshold.

ê 97/23/EC (adapted)

The test pressure must Ö shall Õ be determined
on the basis of the differences between the values of the geometrical and
material characteristics measures under test conditions and the values used for
design purposes; it must
Ö shall Õ take into
account the differences between the test and design temperatures;

(b)        where the risk of creep or
fatigue exists, appropriate tests determined on the basis of the service
conditions laid down for the equipment, for instance hold time at specified
temperatures, number of cycles at specified stress-levels,
etc.;

(c)        where necessary, additional
tests concerning other factors referred to in 2.2.1 such as corrosion, external
damage,
etc.

2.3. Provisions to ensure safe
handling and operation

The method of operation specified for
pressure equipment must
Ö shall Õ be such as to
preclude any reasonably foreseeable risk in operation of the equipment.
Particular attention must Ö shall Õ be paid, where
appropriate, to:

ê 97/23/EC

– 
closures and openings,;

– 
dangerous discharge of pressure relief blow-off,;

– 
devices to prevent physical access whilst
pressure or a vacuum exists,;

– 
surface temperature taking into consideration
the intended use,;

– 
decomposition of unstable fluids.

ê 97/23/EC
(adapted)

In particular, pressure equipment fitted
with an access door must
Ö shall Õ be equipped
with an automatic or manual device enabling the user easily to ascertain that
the opening will not present any hazard Ö risk Õ . Furthermore,
where the opening can be operated quickly, the pressure equipment must Ö shall Õ be fitted with
a device to prevent it being opened whenever the pressure or temperature of the
fluid presents a hazard
Ö risk Õ .

2.4. Means of examination

(a)        Pressure equipment must Ö shall Õ be designed
and constructed so that all necessary examinations to ensure safety can be
carried out;

(b)        Means of determining the
internal condition of the equipment must Ö shall Õ be available,
where it is necessary to ensure the continued safety of the equipment, such as
access openings allowing physical access to the inside of the pressure
equipment so that appropriate examinations can be carried out safely and
ergonomically;

(c)        Other means of ensuring the safe
condition of the pressure equipment may be applied Ö in any of
the following situations Õ :

– 
where it is too small for physical internal
access,
or;

– 
where opening the pressure equipment would
adversely affect the inside, or;

ê 97/23/EC

– 
where the substance contained has been shown not
to be harmful to the material from which the pressure equipment is made and no
other internal degradation mechanisms are reasonably foreseeable.

2.5. Means of draining and venting

ê 97/23/EC
(adapted)

Adequate means must Ö shall Õ be provided
for the draining and venting of pressure equipment where necessary:

– 
to avoid harmful effects such as water hammer,
vacuum collapse, corrosion and uncontrolled chemical reactions. All stages of
operation and testing, particularly pressure testing, must Ö shall Õ be considered,;

ê 97/23/EC

– 
to permit cleaning, inspection and maintenance
in a safe manner.

2.6. Corrosion or other chemical
attack

ê 97/23/EC
(adapted)

Where necessary, adequate allowance or
protection against corrosion or other chemical attack must Ö shall Õ be provided,
taking due account of the intended and reasonably foreseeable use.

2.7. Wear

Where severe conditions of erosion or
abrasion may arise, adequate measures must Ö shall Õ be taken to:

ê 97/23/EC

– 
minimize that effect by appropriate design, e.g.
additional material thickness, or by the use of liners or cladding materials,;

– 
permit replacement of parts which are most
affected,;

– 
draw attention, in the instructions referred to
in point 3.4, to measures
necessary for continued safe use.

2.8. Assemblies

ê 97/23/EC
(adapted)

Assemblies must Ö shall Õ be so designed
that:

ê 97/23/EC

– 
the components to be assembled together are
suitable and reliable for their duty,;

– 
all the components are properly integrated and
assembled in an appropriate manner.

2.9. Provisions for filling and
discharge

ê 97/23/EC
(adapted)

Where appropriate, the pressure equipment must Ö shall Õ be so designed
and provided with accessories, or provision made for their fitting, as to
ensure safe filling and discharge in particular with respect to hazards
Ö risks Õ such as:

ê 97/23/EC

(a)        on filling:

– 
overfilling or overpressurization having regard
in particular to the filling ratio and to vapour pressure at the reference
temperature,;

– 
instability of the pressure equipment;

(b)        on discharge: the uncontrolled
release of the pressurized fluid;

(c)        on filling or discharge: unsafe
connection and disconnection.

2.10. Protection against exceeding the
allowable limits of pressure equipment

ê 97/23/EC
(adapted)

Where, under reasonably foreseeable
conditions, the allowable limits could be exceeded, the pressure equipment must Ö shall Õ be fitted
with, or provision made for the fitting of, suitable protective devices, unless
the equipment is intended to be protected by other protective devices within an
assembly.

The suitable device or combination of such
devices must
Ö shall Õ be determined
on the basis of the particular characteristics of the equipment or assembly.

ê 97/23/EC

Suitable protective devices and
combinations thereof comprise:

(a)        safety accessories as defined in
Article 12(4),
section
2.1.3,

(b)        where appropriate, adequate
monitoring devices such as indicators and/or alarms which enable adequate
action to be taken either automatically or manually to keep the pressure
equipment within the allowable limits.

2.11. Safety accessories

ê 97/23/EC
(adapted)

2.11.1. Safety accessories must Ö shall Õ:

ê 97/23/EC

– 
be so designed and constructed as to be reliable
and suitable for their intended duty and take into account the maintenance and
testing requirements of the devices, where applicable,;

– 
be independent of other functions, unless their
safety function cannot be affected by such other functions,;

– 
comply with appropriate design principles in
order to obtain suitable and reliable protection. These principles include, in
particular, fail-safe modes, redundancy, diversity and self-diagnosis.

2.11.2. Pressure limiting devices

ê 97/23/EC
(adapted)

These devices must Ö shall Õ be so designed
that the pressure will not permanently exceed the maximum allowable pressure
PS; however a short duration pressure surge in keeping with the specifications
laid down in 7.3 is allowable, where appropriate.

2.11.3. Temperature monitoring devices

These devices must Ö shall Õ have an
adequate response time on safety grounds, consistent with the measurement
function.

2.12. External fire

Where necessary, pressure equipment must Ö shall Õ be so designed
and, where appropriate, fitted with suitable accessories, or provision made for
their fitting, to meet damage-limitation requirements in the event of external
fire, having particular regard to its intended use.

3. MANUFACTURING

3.1. Manufacturing procedures

The manufacturer must Ö shall Õ ensure the
competent execution of the provisions set out at the design stage by applying
the appropriate techniques and relevant procedures, especially with a view to
the aspects set out below.

3.1.1. Preparation of the component
parts

Preparation of the component parts (e.g.
forming and chamfering) must Ö shall Õ not give rise
to defects or cracks or changes in the mechanical characteristics likely to be
detrimental to the safety of the pressure equipment.

3.1.2. Permanent joining

Permanent joints and adjacent zones must Ö shall Õ be free of any
surface or internal defects detrimental to the safety of the equipment.

The properties of permanent joints must Ö shall Õ meet the
minimum properties specified for the materials to be joined unless other
relevant property values are specifically taken into account in the design
calculations.

For pressure equipment, permanent joining
of components which contribute to the pressure resistance of equipment and
components which are directly attached to them must Ö shall Õ be carried out
by suitably qualified personnel according to suitable operating procedures.

For pressure equipment in categories II,
III and IV, operating procedures and personnel must Ö shall Õ be approved by
a competent third party which, at the manufacturer's discretion, may be:

ê 97/23/EC

– 
a notified body,;

– 
a third-party organization recognized by a
Member State as provided for in Article 1320.

ê 97/23/EC
(adapted)

ð new

To carry out these approvals the third
party must perform examinations and tests as set out in the appropriate
harmonised standards or equivalent examinations and tests or must Ö shall Õ have them
performed.

3.1.3. Non-destructive tests

For pressure equipment, non-destructive
tests of permanent joints must Ö shall Õ be carried out
by suitable qualified personnel. For pressure equipment in categories III and
IV, the personnel must
Ö shall Õ be approved by
a third-party organizsation recognized by a Member State
pursuant to Article 1320.

3.1.4. Heat treatment

Where there is a risk that the
manufacturing process will change the material properties to an extent which
would impair the safety of the pressure equipment, suitable heat treatment must Ö shall Õ be applied at
the appropriate stage of manufacture.

3.1.5. Traceability

Suitable procedures must Ö shall Õ be established
and maintained for identifying the material making up the components of the
equipment which contribute to pressure resistance by suitable means from
receipt, through production, up to the final test of the manufactured pressure
equipment.

3.2. Final assessment

Pressure equipment must Ö shall Õ be subjected
to final assessment as described below.

3.2.1. Final inspection

Pressure equipment must Ö shall Õ undergo a
final inspection to assess visually and by examination of the accompanying
documents compliance with the requirements of the Directive. Test carried out
during manufacture may be taken into account. As far as is necessary on safety
grounds, the final inspection must Ö shall Õ be carried out
internally and externally on every part of the equipment, where appropriate in
the course of manufacture (e.g. where examination during the final inspection
is no longer possible).

3.2.2. Proof test

Final assessment of pressure equipment must Ö shall Õ include a test
for the pressure containment aspect, which will normally take the form of a
hydrostatic pressure test at a pressure at least equal, where appropriate, to
the value laid down in 7.4.

For category I series-produced pressure
equipment, this test may be performed on a statistical basis.

Where the hydrostatic pressure test is
harmful or impractical, other tests of a recognized value may be carried out.
For tests other than the hydrostatic pressure test, additional measures, such
as non-destructive tests or other methods of equivalent validity, must Ö shall Õ be applied
before those tests are carried out.

3.2.3. Inspection of safety devices

For assemblies, the final assessment must Ö shall Õ also include a
check of the safety devices intended to check full compliance with the
requirements referred to in 2.10.

3.3. Marking and labelling

In addition to the CE marking referred to
in Articles 15
18 and 19, the following
information must
Ö shall Õ be provided:

(a)        for all pressure equipment:

– 
the name and address or other means of
identification of the manufacturer and, where appropriate, of his authorized representative established within
the Community ð the importer ï ,;

ê 97/23/EC

– 
the year of manufacture,;

– 
identification of the pressure equipment
according to its nature, such as type, series or batch identification and
serial number,;

– 
essential maximum/minimum allowable limits;.

(b)        depending on the type of
pressure equipment, further information necessary for safe installation,
operation or use and, where applicable, maintenance and periodic inspection
such as:

– 
the volume V of the pressure equipment in L,;

– 
the nominal size for piping DN,;

– 
the test pressure PT applied in bar and date,;

– 
safety device set pressure in bar,;

– 
output of the pressure equipment in kW,;

– 
supply voltage in V (volts),;

– 
intended use,;

– 
filling ratio kg/L,;

– 
maximum filling mass in kg,;

– 
tare mass in kg,;

ê 97/23/EC

ð new

– 
the product
ð fluid ï group;.

ê 97/23/EC

(c)        where necessary, warnings fixed
to the pressure equipment drawing attention to misuse which experience has
shown might occur.

ê 97/23/EC
(adapted)

The CE marking and the required information
must
Ö shall Õ be given on
the pressure equipment or on a dataplate firmly attached to it, with the
following exceptions:

ê 97/23/EC

– 
where applicable, appropriate documentation may
be used to avoid repetitive marking of individual parts such as piping
components, intended for the same assembly. This applies to CE marking and
other marking and labelling referred to in this Annex;

– 
where the pressure equipment is too small, e.g.
accessories, the information referred to in point (b)
may be given on a label attached to that pressure equipment;

– 
labelling or other adequate means may be used
for the mass to be filled and the warnings referred to in point (c), provided it remains legible
for the appropriate period of time.

3.4. Operating instructions

ê 97/23/EC
(adapted)

ð new

(a)        When pressure equipment is placed ð made available ï on the market, it must Ö shall Õ be
accompanied, as far as relevant, with instructions for the user, containing all
the necessary safety information relating to:

ê 97/23/EC

– 
mounting including assembling of different
pieces of pressure equipment,;

– 
putting into service,;

– 
use,;

– 
maintenance including checks by the user;.

ê 97/23/EC
(adapted)

(b)        Instructions must Ö shall Õ cover
information affixed to the pressure equipment in accordance with 3.3, with the
exception of serial identification, and must Ö shall Õ be
accompanied, where appropriate, by the technical documents, drawings and diagrams
Ö schemes Õ necessary for
a full understanding of these instructions;

(c)        If appropriate, these
instructions must
Ö shall Õ also refer to hazards
Ö risks Õ arising from
misuse in accordance with 1.3 and particular features of the design in
accordance with 2.2.3.

4. MATERIALS

Materials used for the manufacture of
pressure equipment must
Ö shall Õ be suitable
for such application during the scheduled lifetime unless replacement is
foreseen.

ê 97/23/EC

Welding consumables and other joining
materials need fulfil only the relevant requirements of 4.1, 4.2 (a) and the
first paragraph of 4.3, in an appropriate way, both individually and in a
joined structure.

ê 97/23/EC
(adapted)

4.1. Materials for pressurizsed parts must Ö shall Õ:

(a)        have appropriate properties for
all operating conditions which are reasonably foreseeable and for all test
conditions, and in particular they should be sufficiently ductile and tough.
Where appropriate, the characteristics of the materials must Ö shall Õ comply with
the requirements of 7.5. Moreover, due care should be exercised in particular
in selecting materials in order to prevent brittle-type fracture where
necessary; where for specific reasons brittle material has to be used
appropriate measures must Ö shall Õ be taken;

(b)        be sufficiently chemically
resistant to the fluid contained in the pressure equipment; the chemical and
physical properties necessary for operational safety must Ö shall Õ not be
significantly affected within the scheduled lifetime of the equipment;

ê 97/23/EC

(c)        not be significantly affected by
ageing;

(d)        be suitable for the intended
processing procedures;

(e)        be selected in order to avoid
significant undesirable effects when the various materials are put together.

ê 97/23/EC
(adapted)

4.2. Ö The
pressure equipment manufacturer shall Õ:

(a)        The pressure equipment manufacturer must
define in an appropriate manner the values necessary for the design
calculations referred to in 2.2.3 and the essential characteristics of the
materials and their treatment referred to in 4.1;

(b)        the manufacturer must provide
in his technical documentation elements relating to compliance with the
materials specifications of the Directive in one of the following forms:

ê 97/23/EC

– 
by using materials which comply with harmonised
standards,;

– 
by using materials covered by a European
approval of pressure equipment materials in accordance with Article 1115,;

– 
by a particular material appraisal;.

ê 97/23/EC
(adapted)

(c)        for pressure equipment in
categories III and IV, Ö a
specific assessment of the Õ particular Ö material Õ
appraisal as
referred to in the third indent of (b) must Ö shall Õ be performed
by the notified body in charge of conformity assessment procedures for the
pressure equipment.

4.3. The equipment manufacturer must Ö shall Õ take
appropriate measures to ensure that the material used conforms with the
required specification. In particular, documentation prepared by the material
manufacturer affirming compliance with a specification must Ö shall Õ be obtained
for all materials.

For the main pressure-bearing parts of
equipment in categories II, III and IV, this must Ö shall Õ take the form
of a certificate of specific product control.

Where a material manufacturer has an
appropriate quality-assurance system, certified by a competent body established
within the Community
Ö Union Õ and having
undergone a specific assessment for materials, certificates issued by the
manufacturer are presumed to certify conformity with the relevant requirements
of this section point.

ê 97/23/EC

SPECIFIC
PRESSURE EQUIPMENT REQUIREMENTS

In addition to the applicable requirements
of sections
points 1 to 4, the following
requirements apply to the pressure equipment covered by sections
points 5 and 6.

5. FIRED OR OTHERWISE HEATED PRESSURE EQUIPMENT WITH A RISK OF
OVERHEATING AS REFERRED TO IN ARTICLE 34 (1)

This pressure equipment includes:

ê 97/23/EC
(adapted)

– 
steam and hot-water generators as referred to in
Article 34(b),
section
1.2, such as fired steam and hot-water boilers,
superheaters and reheaters, waste-heat boilers, waste incineration boilers,
electrode or immersion-type electrically heated boilers, pressure cookers,
together with their accessories and where applicable their systems for
treatment of feedwater and for fuel supply,; and

– 
process-heating equipment for other than steam
and hot water generation falling under Article 34(a), section 1.1, such
as heaters for chemical and other similar processes and pressurizsed food-processing equipment.

This pressure equipment must Ö shall Õ be calculated,
designed and constructed so as to avoid to Ö or Õ minimize risks
of a significant loss of containment from overheating. In particular it must Ö shall Õ be ensured,
where applicable, that:

ê 97/23/EC

(a)        appropriate means of protection
are provided to restrict operating parameters such as heat input, heat take-off
and, where applicable, fluid level so as to avoid any risk of local and general
overheating,;

(b)        sampling points are provided
where required to allow evaluation of the properties of the fluid so as to
avoid risks related to deposits and/or corrosion,;

(c)        adequate provisions are made to
eliminate risks of damage from deposits,;

(d)        means of safe removal of
residual heat after shutdown are provided,;

(e)        steps are taken to avoid a
dangerous accumulation of ignitable mixtures of combustible substances and air,
or flame blowback.

ê 97/23/EC
(adapted)

6. PIPING AS REFERRED TO IN ARTICLE 34 (c), SECTION 1.3

Design and construction must Ö shall Õ ensure:

ê 97/23/EC

(a)        that the risk of overstressing
from inadmissible free movement or excessive forces being produced, e.g. on
flanges, connections, bellows or hoses, is adequately controlled by means such
as support, constraint, anchoring, alignment and pre-tension;

(b)        that where there is a
possibility of condensation occurring inside pipes for gaseous fluids, means
are provided for drainage and removal of deposits from low areas to avoid
damage from water hammer or corrosion;

(c)        that due consideration is given
to the potential damage from turbulence and formation of vortices; the relevant
parts of 2.7 are applicable;

(d)        that due consideration is given
to the risk of fatigue due to vibrations in pipes;

(e)        that, where fluids of Group 1
are contained in the piping, appropriate means are provided to isolate
«take-off» pipes the size of which represents a significant risk;

ê 97/23/EC
(adapted)

(f)         that the risk of inadvertent
discharge is minimized; the take-off points must Ö shall Õ be clearly
marked on the permanent side, indicating the fluid contained;

ê 97/23/EC

(g)        that the position and route of
underground piping is at least recorded in the technical documentation to
facilitate safe maintenance, inspection or repair.

7. SPECIFIC QUANTITATIVE REQUIREMENTS
FOR CERTAIN PRESSURE EQUIPMENT

ê 97/23/EC
(adapted)

The following provisions apply as a general
rule. However, where they are not applied, including in cases where materials
are not specifically referred to and no harmonised standards are applied, the
manufacturer must
Ö shall Õ demonstrate
that appropriate measures have been taken to achieve an equivalent overall
level of safety.

This section is an integral part of Annex I. The provisions laid down in this section supplement the essential Ö safety Õ requirements
of sections
points 1 to 6 for the pressure
equipment to which they apply.

ê 97/23/EC

7.1. Allowable stresses

7.1.1. Symbols

Re/t, yield limit, indicates the value at the calculation temperature
of:

– 
the upper flow limit for a material presenting
upper and lower flow limits,;

– 
the 1,0 % proof strength of austenitic
steel and non-alloyed aluminium,;

– 
the 0,2 % proof strength in other cases.

ê 97/23/EC
(adapted)

Rm/20 indicates the minimum value of the ultimate Ö tensile Õ strength Ö at Õ 20 °C.

Rm/t designates the ultimate Ö tensile Õ strength at
the calculation temperature.

7.1.2. The permissible general membrane
stress for predominantly static loads and for temperatures outside the range in
which creep is significant must Ö shall Õ not exceed the
smaller of the following values, according to the material used:

ê 97/23/EC

– 
in the case of ferritic steel including
normalized (normalized rolled) steel and excluding fine-grained steel and
specially heat-treated steel, 2/3 of Re/t and 5/12
of Rm/20;

– 
in the case of austenitic steel:

– 
if its elongation after rupture exceeds
30 %, 2/3 of Re/t

– 
or, alternatively, and if its elongation after
rupture exceeds 35 %, 5/6 of Re/t
and 1/3 of Rm/t;

– 
in the case of non-alloy or low-alloy cast
steel, 10/19 of Re/t and 1/3
of Rm/20;

– 
in the case of aluminium, 2/3
of Re/t;

– 
in the case of aluminium alloys excluding
precipitation hardening alloys 2/3 of Re/t
and 5/12 of Rm/20.

7.2. Joint coefficients

ê 97/23/EC (adapted)

For welded joints, the joint coefficient must Ö shall Õ not exceed the
following values:

ê 97/23/EC

– 
for equipment subject to destructive and
non-destructive tests which confirm that the whole series of joints show no
significant defects: 1,;

– 
for equipment subject to random non-destructive
testing: 0,85,;

– 
for equipment not subject to non-destructive
testing other than visual inspection: 0,7.

ê 97/23/EC
(adapted)

If necessary, the type of stress and the
mechanical and technological properties of the joint must Ö shall Õ also be taken
into account.

7.3. Pressure limiting devices,
particularly for pressure vessels

The momentary pressure surge referred to in
2.11.2 must
Ö shall Õ be kept to
10 % of the maximum allowable pressure.

7.4. Hydrostatic test pressure

For pressure vessels, the hydrostatic test
pressure referred to in 3.2.2 must Ö shall Õ be no less
than Ö either of
the following Õ:

– 
that corresponding to the maximum loading to
which the pressure equipment may be subject in service taking into account its
maximum allowable pressure and its maximum allowable temperature, multiplied by
the coefficient 1,25,; or

– 
the maximum allowable pressure multiplied by the
coefficient 1,43, whichever is the greater.

7.5. Material characteristics

Unless other values are required in
accordance with other criteria that must Ö shall Õ be taken into
account, a steel is considered as sufficiently ductile to satisfy 4.1 (a) if,
in a tensile test carried out by a standard procedure, its elongation after
rupture is no less than 14 % and its bending rupture energy measured on an
ISO V test-piece is no less than 27 J, at a temperature not greater than
20 °C but not higher than the lowest scheduled operating temperature.

ê 97/23/EC

ANNEX II

CONFORMITY ASSESSMENT TABLES

1. The references in the tables to
categories of modules are the following:

ê 97/23/EC
(adapted)

I || = || Module A

II || = || Module A12, D1, E1

III || = || Modules B1 Ö (design type) Õ + D, B1 Ö (design type) Õ + F, B Ö (combination of production type and design type) Õ + E, B Ö (combination of production type and design type) Õ + C12, H

IV || = || Modules B Ö (combination of production type and design type) Õ + D, B Ö (combination of production type and design type) Õ + F, G, H1

2. The safety accessories defined in
Article 12(4),
Section
2.1.3, and referred to in Article 34(1)(d), Section
1.4, are classified in category IV. However, by way of
exception, safety accessories manufactured for specific equipment may be
classified in the same category as the equipment they protect.

3. The pressure accessories defined in
Article 12(5),
Section
2.1.4, and referred to in Article 34(1)(d), Section
1.4, are classified on the basis of:

– 
their maximum allowable pressure PS,; and

– 
their volume V or their nominal size DN, as
appropriate,;
and

– 
the group of fluids for which they are intended,.

and tThe appropriate table for vessels or
piping is to be used to determine the conformity assessment category.

Where both the volume and the nominal size
are considered appropriate in the second indent Ö of the
first subparagraph Õ, the pressure
accessory must
Ö shall Õ be classified
in the highest category.

ê 97/23/EC

4. The demarcation lines in the following
conformity assessment tables indicate the upper limit for each category.

ê 97/23/EC
(adapted)

Ö Õ

Table 1

Vessels referred to in Article 34, Section 1.1 (1)(a)(i), first indent

Exceptionally, vessels intended to contain
an unstable gas and falling within categories I or II on the basis of table 1 must Ö shall Õ be classified
in category III.

Ö Õ

Table 2

Vessels referred to in Article 34, Section 1.1 (1)(a)(i), second indent

Exceptionally, portable extinguishers and
bottles for breathing equipment must Ö shall Õ be classified
at least in category III.

Ö Õ

Table 3

Vessels referred to in Article 34, Section 1.1 (1)(ba)(ii), first indent

Ö Õ

Table 4

Vessels referred to in Article 34(1)(a)(ii), Section 1.1 (b), second indent

Exceptionally, assemblies intended for
generating warm water as referred to in Article 34 (2)(c), Section
2.3, must Ö shall Õ be subject
either to an EC design Ö EU-type Õ examination
(Module B1 Ö - design
type Õ ) with respect
to their conformity with the essential requirements referred to in Sections
points 2.10, 2.11, 3.4, 5 (a) and
5 (d) of Annex I, or to full quality assurance (Module H).

Ö Õ

Table 5

Pressure equipment referred to in
Article 34(1)(b), Section 1.2

Exceptionally, the design of
pressure-cookers must
Ö shall Õ be subject to
a conformity assessment procedure equivalent to at least one of the category
III modules.

Ö Õ

Table 6

Piping referred to in Article 34(1)(c)(i), Section 1.3 (a), first indent

Exceptionally, piping intended for unstable
gases and falling within categories I or II on the basis of Table 6 must Ö shall Õ be classified
in category III.

Ö Õ

Table 7

Piping referred to in Article 34(1)(c)(i), Section 1.3 (a), second indent

Exceptionally, all piping containing fluids
at a temperature greater than 350 °C and falling within category II on the
basis of Table 7 must
Ö shall Õ be classified
in category III.

Ö Õ

Table 8

Piping referred to in Article 34(1)(c)(ii), Section 1.3 (b), first indent

Ö Õ

Table 9

Piping referred to in Article 34(1)(c)(ii), Section 1.3 (b), second indent

ê 97/23/EC

ANNEX III

CONFORMITY ASSESSMENT PROCEDURES

The obligations arising from the provisions
on pressure equipment in this Annex also apply to assemblies.

1. Module A: (internal
production control)

1. This module
describes the procedure whereby the manufacturer or his authorized
representative established within the Community who carries out the obligations
laid down in section 2 ensures and declares that pressure equipment satisfies
the requirements of the Directive which apply
to it.

The manufacturer,
or his authorized representative established within the Community, must affix
the CE marking to each item of pressure equipment and draw up a written
declaration of conformity.

ò new

1.         Internal
production control is the conformity assessment procedure whereby the
manufacturer fulfils the obligations laid down in points 2, 3 and 4, and
ensures and declares on his sole responsibility that the pressure equipment
concerned satisfy the requirements of this Directive.

ê 97/23/EC (adapted)

2. Ö Technical
documentation Õ

The manufacturer must draw up Ö shall
establish Õ the technical
documentation. described in section 3 and either the manufacturer
or his authorized representative established within the Community must keep
it at the disposal of the relevant national authorities for inspection purposes
for a period of ten years after the last of the pressure equipment has been
manufactured.

ê 97/23/EC

Where neither the
manufacturer nor his authorized representative is established within the
Community, the obligation to keep the technical documentation available is the
responsibility of the person who places the pressure equipment on the Community
market.

ê 97/23/EC
(adapted)

ð new

3. The technical documentation must enable Ö shall make
it possible to Õ an
assessment
to be made of
the conformity of the pressure equipment with Ö to Õ the Ö relevant Õ requirements ð, and shall include an adequate analysis
and assessment of the risk(s). ï Ö The
technical documentation shall specify the applicable requirements and
cover, Õ of the Directive which
apply to it. It must, as far as is relevant for such Ö the Õ assessment, cover
the design, manufacture and operation of the pressure equipment. Ö The
technical documentation shall, wherever applicable, Õ and
contain Ö at least
the following elements Õ :

ê 97/23/EC

– 
a general description of the pressure equipment,;

ê 97/23/EC
(adapted)

ð new

– 
conceptual design and manufacturing drawings and
diagrams
Ö schemes Õ of components,
sub-assemblies, circuits, etc.,;

– 
descriptions and explanations necessary for an
understanding of the
said
Ö those Õ drawings and diagrams
Ö schemes Õ and the
operation of the pressure equipment,;

– 
a list of the Ö harmonised Õ standards referred to in Article 5
Ö the
references of which have been published in the Official Journal of the European
Union Õ, applied in
full or in part, and a description of the solutions adopted to meet the essential
Ö safety Õ requirements
of the
Ö this Õ Directive
where the
Ö those harmonised Õ standards referred to in Article 5
have not been applied,. ð In the event of partly applied
harmonised standards, the technical documentation shall specify the parts which
have been applied; ï

ê 97/23/EC

– 
results of design calculations made,
examinations carried out, etc.,;

– 
test reports.

4. The
manufacturer, or his authorized representative established within the Community,
must keep a copy of the declaration of conformity with the technical
documentation.

ê 97/23/EC
(adapted)

ð new

53. Ö Manufacturing Õ

The manufacturer must Ö shall Õ take all
measures necessary to
ensure Ö so Õ that the manufacturing
process ð and its monitoring ï Ö ensure
compliance of Õ requires
the manufactured pressure equipment to comply with the
technical documentation referred to in section point 2 and with the requirements
of the
Ö this Õ Directive which apply to it.

Ö 4.   CE
marking and EU declaration of conformity Õ

4.1.      The manufacturer, or his
authorized representative established within the Community,
must
Ö shall Õ affix the CE
marking to each item
Ö individual Õ of
pressure equipment and draw up a written declaration
of conformity Ö that
satisfies the applicable requirements of this Directive Õ .

ò new

4.2.      The
manufacturer shall draw up a written EU declaration of conformity for the
pressure equipment model and keep it together with the technical documentation
at the disposal of the national authorities for 10 years after the pressure
equipment has been placed on the market. The EU declaration of conformity shall
identify the pressure equipment for which it has been drawn up.

A copy of the EU declaration
of conformity shall be made available to the relevant authorities upon request.

5.         Authorised
representative

The
manufacturer's obligations set out in point 4 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided that they are specified in the
mandate.

ê 97/23/EC

Module
A1 (internal manufacturing checks with monitoring of the final assessment)

In addition to the
requirements of module A, the following applies.

Final
assessment must be performed by the manufacturer and monitored by means of
unexpected visits by a notified body chosen by the manufacturer.

During such
visits, the notified body must:

– 
establish that the
manufacturer actually performs final assessment in accordance with section
3.2 of Annex I,

– 
take samples of
pressure equipment at the manufacturing or storage premises in order to conduct
checks. The notified body assesses the number of items of equipment to sample
and whether it is necessary to perform, or have performed, all or part of
the final assessment of the pressure equipment samples.

Should one or more
of the items of pressure equipment not conform, the notified body must take
appropriate measures.

On the
responsibility of the notified body, the manufacturer must affix the
former's identification number on each item of pressure equipment.

ò new

2. Module A2: Internal production
control plus supervised pressure equipment checks at random intervals

1.         Internal
production control plus final assessment performed by the manufacturer and
monitored by means of unexpected visits by a notified body chosen by the
manufacturer is the conformity assessment procedure whereby the manufacturer
fulfils the obligations laid down in points 2, 3, 4, and 5, and ensures and
declares on his sole responsibility that the pressure equipment concerned
satisfy the requirements of this Directive.

2.         Technical
documentation

The manufacturer
shall establish the technical documentation. The documentation shall make it
possible to assess the conformity of the pressure equipment with the relevant
requirements, and shall include an adequate analysis and assessment of the
risk(s). The technical documentation shall specify the applicable requirements
and cover, as far as relevant for the assessment, the design, manufacture and
operation of the pressure equipment. The technical documentation shall contain,
wherever applicable, at least the following elements:

– a general description of the pressure
equipment;

– conceptual design and manufacturing
drawings and schemes of components, sub‑assemblies, circuits, etc.;

– descriptions and explanations necessary
for the understanding of those drawings and schemes and the operation of the
pressure equipment;

– a list of the harmonised standards the
references of which have been published in the Official Journal of the
European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential safety requirements of this Directive
where those harmonised standards have not been applied. In the event of partly
applied harmonised standards, the technical documentation shall specify the
parts which have been applied;

– results of design calculations made,
examinations carried out, etc., and

– test reports.

3.         Manufacturing

The manufacturer
shall take all measures necessary so that the manufacturing process and its
monitoring ensure compliance of the manufactured pressure equipment with the
technical documentation referred to in point 2 and with the requirements of
this Directive that apply to it.

4.         Final
assessment and pressure equipment checks

The manufacturer shall
perform a final assessment of the pressure equipment, monitored by means of unexpected visits by a notified body
chosen by the manufacturer.

The notified body
shall carry out product checks or have them carried out at random intervals
determined by the body, in order to verify the quality of the internal checks
of the pressure equipment, taking into account inter alia the technological
complexity of the pressure equipment and the quantity of production.

During its
unexpected visits, the notified body shall:

– establish that the manufacturer actually
performs final assessment in accordance with point 3.2 of Annex I.

– take samples of pressure equipment at the
manufacturing or storage premises in order to conduct checks. The notified body
assesses the number of items of equipment to sample and whether it is necessary
to perform, or have performed, all or part of the final assessment of the
pressure equipment samples.

The acceptance
sampling procedure to be applied is intended to determine whether the
manufacturing process of the pressure equipment performs within acceptable
limits, with a view to ensuring conformity of the pressure equipment.

Should one or
more of the items of pressure equipment or assembly not conform, the notified
body shall take appropriate measures.

The manufacturer
shall, under the responsibility of the notified body, affix the notified body's
identification number during the manufacturing process.

5.         CE
marking and EU declaration of conformity

5.1.      The
manufacturer shall affix the CE marking to each individual pressure equipment
that satisfies the applicable requirements of this Directive.

5.2.      The
manufacturer shall draw up a written EU declaration of conformity for the pressure
equipment model and keep it together with the technical documentation at the
disposal of the national authorities for 10 years after the pressure equipment
has been placed on the market. The EU declaration of conformity shall identify
the pressure equipment for which it has been drawn up.

A copy of the EU declaration
of conformity shall be made available to the relevant authorities upon request.

6.         Authorised
representative

The
manufacturer's obligations set out in point 5 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided
that they are specified in the mandate.

ê 97/23/EC
(adapted)

3. Module
B: (EC type- Ö EU-type Õ examination)

Ö 3.1. EU-type
examination – combination of production type and design type Õ

ê 97/23/EC

1. This module
describes the part of the procedure by which a notified body ascertains and
attests that a representative example of the production in question meets
the provisions of the Directive which apply to it.

2. The application
for EC type-examination must be lodged by the manufacturer or by his authorized
representative established within the Community with a single notified body
of his choice.

ò new

1.         EU-type
examination - combination of production type and design type is the part of a
conformity assessment procedure in which a notified body examines the technical
design of the pressure equipment and verifies and attests that the technical
design of the pressure equipment meets the requirements of this Directive.

2.         EU-type
examination - combination of production type and design type shall consist of
an assessment of the adequacy of the technical design of the pressure equipment
through examination of the technical documentation and supporting evidence
referred to in point 3, plus examination of specimens, representative of the
production envisaged, of one or more critical parts of the pressure equipment.

3.         The
manufacturer shall lodge an application for EU-type examination with a single
notified body of his choice.

ê 97/23/EC
(adapted)

The application must Ö shall Õ include:

ê 97/23/EC

– 
the name and address of the manufacturer and, if
the application is lodged by the authorized representative, his name and
address as well,;

– 
a written declaration that the same application
has not been lodged with any other notified body,;

ê 97/23/EC
(adapted)

– 
the technical documentation described in section 3.

ê 97/23/EC

The applicant must
place at the disposal of the notified body a representative example of the
production envisaged, hereinafter called «type». The notified body may request
further examples should the test programme so require.

A type may cover
several versions of pressure equipment provided that the differences between
the versions do not affect the level of safety.

ê 97/23/EC
(adapted)

ð new

– 
3. Ö the
technical documentation. Õ The technical
documentation must enable Ö shall make
it possible to Õ an
assessment to be
made of the conformity of the pressure equipment with the Ö applicable Õ requirements
of the Ö this Õ Directive ð and shall include an adequate
analysis and assessment of the risk(s). ï which
apply to it. It must Ö The
technical documentation shall specify the applicable requirements and
cover Õ, as far as is
relevant for such
Ö the Õ assessment, cover
the design, manufacture and operation of the pressure equipment. Ö The
technical documentation shall Õ and
contain Ö ,
wherever applicable, at least the following elements Õ :

– 
a general description of the type Ö pressure
equipment Õ ,;

– 
conceptual design and manufacturing drawings and
diagrams
Ö schemes Õ of components,
sub-assemblies, circuits, etc.,;

ê 97/23/EC
(adapted)

ð new

– 
descriptions and explanations necessary for an Ö the Õ understanding
of the
Ö those Õ said
drawings and diagrams
Ö schemes Õ and the
operation of the pressure equipment,;

– 
a list of the Ö harmonised Õ standards referred to in Article
5 Ö the
references of which have been published in the Official Journal of the
European Union Õ, applied in
full or in part, and descriptions of the solutions adopted to meet the
essential Ö safety Õ requirements
of the
Ö this Õ Directive where
the
Ö those
harmonised Õ standards referred to in Article 5
have not been applied,. ð In the event of partly applied
harmonised standards, the technical documentation shall specify the parts which
have been applied; ï

ê 97/23/EC

– 
results of design calculations made,
examinations carried out, etc.,;

– 
test reports,;

– 
information concerning the tests provided for in
manufacture,;

– 
information concerning the qualifications or
approvals required under sections points 3.1.2 and 3.1.3 of Annex I.;

ò new

– 
the specimens
representative of the production envisaged;

The specimen may
cover several versions of the pressure equipment provided that the differences
between the versions do not affect the level of safety.

The notified body
may request further specimens if needed for carrying out the test programme;

– 
the supporting
evidence for the adequacy of the technical design solution. This supporting
evidence shall mention any documents that have been used, in particular where
the relevant harmonised standards have not been applied in full. The supporting
evidence shall include, where necessary, the results of tests carried out by
the appropriate laboratory of the manufacturer applying other relevant
technical specifications, or by another testing laboratory on his behalf and
under his responsibility.

ê 97/23/EC
(adapted)

ð new

4. The notified body must Ö shall Õ :

4.1. examine the technical documentation, verify that the type has been manufactured in
conformity with it and identify the components designed in accordance with the
relevant provisions of the standards referred to in Article 5, as well as
those designed without applying the provisions of those standards
ð and supporting evidence to assess
the adequacy of the technical design of the pressure equipment and the
manufacturing procedures ï .

In particular, the notified body must Ö shall Õ:

– 
examine the
technical documentation with respect to the design and the manufacturing
procedures,

– 
assess the materials used where these are not in
conformity with the relevant harmonised standards or with a European approval
for pressure equipment materials, and check the certificate issued by the
material manufacturer in accordance with section point 4.3 of Annex I,;

ê 97/23/EC

– 
approve the procedures for the permanent joining
of pressure equipment parts, or check that they have been previously approved
in accordance with section point 3.1.2 of Annex I,;

– 
verify that the personnel undertaking the
permanent joining of pressure equipment parts and the non-destructive tests are
qualified or approved in accordance with sections points 3.1.2 or 3.1.3 of Annex I.

4.2. perform or
have performed the appropriate examinations and necessary tests to establish
whether the solutions adopted by the manufacturer meet the essential
requirements of the Directive where the standards referred to in Article 5 have
not been applied.

ò new

4.2. verify that
the specimen(s) have been manufactured in conformity with the technical
documentation and identify the elements which have been designed in accordance
with the applicable provisions of the relevant harmonised standards as well as
the elements which have been designed using other relevant technical
specifications without applying the relevant provisions of those standards.

ê 97/23/EC
(adapted)

4.3. perform or have performed the Ö carry
out Õ appropriate
examinations and
necessary tests to establish whether, Ö to
check Õ where Ö whether
when Õ the
manufacturer has chosen to apply Ö the
solutions in Õ the relevant Ö harmonised Õ standards,
these have actually
been applied Ö correctly Õ .

ò new

4.4.      carry out appropriate examinations to check whether, where the
solutions in the relevant harmonised standards have not been applied, the
solutions adopted by the manufacturer applying other relevant technical
specifications meet the corresponding essential safety requirements of this Directive.

4.5.      agree with the manufacturer on a location where the
examinations and tests will be carried out.

ê 97/23/EC

4.4. agree with
the applicant the location where the examinations and necessary tests are to
be carried out.

5. Where the type
satisfies the provisions of the Directive which apply to it, the notified body
must issue an EC type-examination certificate to the applicant. The
certificate, which should be valid for ten years and be renewable, must
contain the name and address of the manufacturer, the conclusions of the
examination and the necessary data for identification of the approved type.

A list of the
relevant parts of the technical documentation must be annexed to the
certificate and a copy kept by the notified body.

If the notified
body refuses to issue an EC type-examination certificate to the manufacturer or
to his authorized representative established within the Community, that body
must provide detailed reasons for such refusal. Provision must be made for
an appeals procedure.

6. The applicant
must inform the notified body that holds the technical documentation concerning
the EC type-examination certificate of all modifications to the approved
pressure equipment; these are subject to additional approval where they may
affect conformity with the essential requirements or the prescribed conditions
for use of the pressure equipment. This additional approval must be given in
the form of an addition to the original EC
type-examination certificate.

7. Each notified
body must communicate to the Member States the relevant information concerning
EC type-examination certificates which it has withdrawn, and, on request, those
it has issued.

Each notified body
must also communicate to the other notified bodies the relevant information
concerning the EC type-examination certificates it has withdrawn or refused.

8. The other
notified bodies may receive copies of the EC type-examination certificates
and/or their additions. The annexes to the certificates must be held at the
disposal of the other notified bodies.

9. The
manufacturer, or his authorized representative established within the
Community, must keep with the technical documentation copies of EC
type-examination certificates and their additions for a period of ten years
after the last of the pressure equipment has been manufactured.

Where neither the
manufacturer nor his authorized representative is established within the
Community, the obligation to keep the technical documentation available is
the responsibility of the person who places the product on the Community
market.

ò new

5.         The
notified body shall draw up an evaluation report that records the activities
undertaken in accordance with point 4 and their outcomes. Without prejudice to
its obligations vis-à-vis the notifying authority, the notified body shall
release the content of that report, in full or in part, only with the agreement
of the manufacturer.

6.         Where
the type meets the requirements of this Directive, the notified body shall
issue an EU-type examination certificate – combination of production type and
design type to the manufacturer. The certificate, which should be valid for 10
years and be renewable, shall contain the name and address of the manufacturer,
the conclusions of the examination, the conditions (if any) for its validity
and the necessary data for identification of the approved type.

A list of the
relevant parts of the technical documentation shall be annexed to the
certificate and a copy kept by the notified body.

The certificate
and its annexes shall contain all relevant information to allow the conformity
of manufactured pressure equipment with the examined type to be evaluated and
to allow for in‑service control.

Where the type
does not satisfy the applicable requirements of this Directive, the notified
body shall refuse to issue an EU‑type examination certificate – combination
of production type and design type and shall inform the applicant accordingly,
giving detailed reasons for its refusal. Provision shall be made for an appeals
procedure.

7.         The
notified body shall keep itself apprised of any changes in the generally
acknowledged state of the art which indicate that the approved type may no
longer comply with the applicable requirements of this Directive, and shall
determine whether such changes require further investigation. If so, the
notified body shall inform the manufacturer accordingly.

The manufacturer
shall inform the notified body that holds the technical documentation relating
to the EU‑type examination certificate – production type of all modifications to the approved type
that may affect the conformity of the pressure equipment with the essential safety
requirements of this Directive or the conditions for validity of the
certificate. Such modifications shall require additional approval in the form
of an addition to the original EU‑ type examination certificate – production type.

8.         Each
notified body shall inform its notifying authority concerning the EU‑type
examination certificates – combination of production type and design type and/or
any additions thereto which it has issued or withdrawn, and shall, periodically
or upon request, make available to its notifying authorities the list of
certificates and/or any additions thereto refused, suspended or otherwise
restricted.

Each notified
body shall inform the other notified bodies concerning the EU-type examination
certificates – combination of production type and design type and/or any additions thereto
which it has refused, withdrawn, suspended or otherwise restricted, and, upon
request, concerning the certificates and/or additions thereto which it has
issued.

The Commission,
the Member States and the other notified bodies may, on request, obtain a copy
of the EU-type examination certificates – combination of production type and design type and/or additions
thereto. On request, the Commission and the Member States may obtain a copy of
the technical documentation and the results of the examinations carried out by
the notified body. The notified body shall keep a copy of the EU‑type
examination certificate – combination of production type and design type, its annexes and additions, as
well as the technical file including the documentation submitted by the
manufacturer, until the expiry of the validity of the certificate.

9.         The manufacturer
shall keep a copy of the EU‑type examination certificate – combination of
production
type and design type, its
annexes and additions together with the technical documentation at the disposal
of the national authorities for 10 years after the pressure equipment has been
placed on the market.

10.       The
manufacturer's authorised representative may lodge the application referred to
in point 3 and fulfil the obligations set out in points 7 and 9, provided that
they are specified in the mandate.

ê 97/23/EC
(adapted)

Module B1 3.2. (EC design-
Ö EU-type Õ examination)
Ö –
design type Õ

ê 97/23/EC

1. This module
describes the part of the procedure whereby a notified body ascertains and
attests that the design of an item of pressure equipment meets the provisions
of the Directive which apply to it.

ò new

1.         EU-type
examination – design type is the part of a conformity assessment procedure in
which a notified body examines the technical design of the pressure equipment
and verifies and attests that the technical design of the pressure equipment
meets the requirements of this Directive.

2.         The EU-type
examination – design type shall consist of an assessment of the adequacy of the
technical design of the pressure equipment through examination of the technical
documentation and supporting evidence referred to in point 3, without
examination of a specimen.

ê 97/23/EC
(adapted)

1. The experimental design method provided for in section
point 2.2.4 of Annex I may Ö shall Õ not be used in
the context of this module.

23. The manufacturer, or his
authorized representative established within the Community, must Ö shall Õ lodge an
application for EC design Ö EU-type Õ examination Ö - design
type Õ with a single
notified body Ö of his
choice Õ .

The application must Ö shall Õ include:

ê 97/23/EC

– 
the name and address of the manufacturer and, if
the application is lodged by the authorized representative, his name and address
as well,;

– 
a written declaration that the same application
has not been lodged with any other notified body,;

ê 97/23/EC
(adapted)

– 
the technical documentation described in section 3.

ê 97/23/EC

The application
may cover several versions of the pressure equipment provided that the
differences between the versions do not affect the level of safety.

ê 97/23/EC
(adapted)

ð new

– 
3. Ö the
technical documentation. Õ The technical
documentation must
enable an Ö shall
make it possible to Õ assessment to be made of
the conformity of the pressure equipment with the Ö applicable Õ requirements
of the Directive which
apply to it ð and shall include an adequate
analysis and assessment of the risk(s) ï . Ö The
technical documentation shall specify the applicable requirements and cover
Õ It must,
as far as is
relevant for such
Ö the Õ assessment, cover
the design, manufacture and operation of the pressure equipment. Ö The
technical documentation shall Õ and contain
Ö ,
wherever applicable, at least the following elements Õ :

– 
a general description of the pressure equipment,;

– 
conceptual design and manufacturing drawings and
diagrams
Ö schemes Õ of components,
sub-assemblies, circuits, etc.,;

– 
descriptions and explanations necessary for an Ö the Õ understanding
of the said Ö those Õ drawings and diagrams
Ö schemes Õ and the
operation of the pressure equipment,;

– 
a list of the Ö harmonised Õ standards referred to in Article 5
Ö the
references of which have been published in the Official Journal of the
European Union Õ, applied in
full or in part, and descriptions of the solutions adopted to meet the
essential Ö safety Õ requirements
of the
Ö this Õ Directive where
the
Ö those
harmonised Õ standards referred to in Article 5
Ö have Õ not been
applied. ð In the event of partly applied
harmonised standards, the technical documentation shall specify the parts which
have been applied; ï

ê 97/23/EC

– 
results of design calculations made,
examinations carried out, etc.,;

– 
information regarding the qualifications
or approvals required under sections points 3.1.2 and 3.1.3 of Annex I.;

ê 97/23/EC
(adapted)

ð new

– 
the necessary supporting evidence
for the adequacy of the Ö technical Õ design
solution,.
ð This supporting evidence shall
mention any documents that have been used, ï in particular where the Ö relevant
harmonised Õ standards referred to in Article
5 have not been applied in full;. the Ö This Õ supporting
evidence must
Ö shall Õ include Ö , where
necessary, Õ the results of
tests carried out by the appropriate laboratory of the manufacturer or Ö by
another testing laboratory Õ on his behalf Ö and under
his responsibility Õ ,.

ò new

The application
may cover several versions of the pressure equipment provided that the
differences between the versions do not affect the level of safety.

ê 97/23/EC
(adapted)

ð new

4. The notified body must Ö shall Õ:

4.1. examine the technical documentation and identify the components which have been
designed in accordance with the relevant provisions of the standards referred
to in Article 5, as well as those which have been designed without applying the
relevant provisions of those standards. ð and
supporting evidence to assess the adequacy of the technical design of the
product. ï

In particular, the notified body must Ö shall Õ:

ê 97/23/EC

– 
assess the materials where these are not in conformity
with the relevant harmonised standards or with a European approval for pressure
equipment materials,;

– 
approve the procedures for the permanent joining
of pressure equipment parts, or check that they have been previously approved
in accordance with section point 3.1.2 of Annex I,.

– 
verify that the
personnel undertaking the permanent joining of pressure equipment parts and the
non-destructive tests are qualified or approved in accordance with sections
3.1.2 and 3.1.3 of Annex I.

ê 97/23/EC
(adapted)

ð new

4.2. perform the necessary Ö carry out
appropriate Õ examinations
to establish
Ö check Õ whether Ö where the
manufacturer has chosen to apply Õ the solutions adopted by the
manufacturer meet the essential requirements of the Directive where the
standards referred to in Article 5 Ö in the
relevant harmonised standards these Õ have not been applied ð correctly ï .

4.3. perform the necessary Ö carry out
appropriate Õ examinations
to establish
Ö check Õ whether, where
the manufacturer
has chosen to apply the relevant standards, these have actually been applied
Ö solutions
in the relevant harmonised standards have not been applied, the solutions
adopted by the manufacturer meet the corresponding essential safety requirements
of this Directive Õ .

ê 97/23/EC

5. Where the
design meets the provisions of the Directive which apply to it, the notified
body must issue an EC design-examination certificate to the applicant. The
certificate must contain the name and address of the applicant, the conclusions
of the examination, conditions for its validity and the necessary data for
identification of the approved design.

A list of the
relevant parts of the technical documentation must be annexed to the
certificate and a copy kept by the notified body.

If the notified
body refuses to issue an EC design-examination certificate to the manufacturer
or to his authorized representative established within the Community, that body
must provide detailed reasons for such refusal. Provision must be made for an
appeals procedure.

6. The applicant
must inform the notified body that holds the technical documentation concerning
the EC design-examination certificate of all modifications to the approved
design; these are subject to additional approval where such changes may affect
the conformity of the pressure equipment with the essential requirements of the
Directive or the prescribed conditions for use of the equipment. This
additional approval must be given in the form of an addition to the original EC
design-examination certificate.

7. Each notified
body must communicate to the Member States the relevant information concerning
EC design-examination certificates which it has withdrawn, and, on request,
those it has issued.

Each notified body
must also communicate to the other notified bodies the relevant information
concerning the EC design-examination certificates it has withdrawn or refused.

8. The other
notified bodies may on request obtain the relevant information concerning:

– 
the EC
design-examination certificates and additions granted,

– 
the EC
design-examination certificates and additions withdrawn.

9. The
manufacturer, or his authorized representative established within the
Community, must keep with the technical documentation referred to in section 3
copies of EC design-examination certificates and their additions for a
period of ten years after the last of the pressure equipment has been
manufactured.

Where neither the
manufacturer nor his authorized representative is established within the
Community, the obligation to keep the technical documentation available is
the responsibility of the person who places the product on the Community
market.

ò new

5.         The
notified body shall draw up an evaluation report that records the activities
undertaken in accordance with point 4 and their outcomes. Without prejudice to
its obligations vis-à-vis the notifying authorities, the notified body shall
release the content of that report, in full or in part, only with the agreement
of the manufacturer.

6.         Where
the design meets the requirements of this Directive, the notified body shall
issue an EU-type examination certificate - design type to the manufacturer. The
certificate, which should be valid for 10 years and be renewable, shall contain
the name and address of the manufacturer, the conclusions of the examination,
the conditions (if any) for its validity and the necessary data for
identification of the approved design.

A list of the
relevant parts of the technical documentation shall be annexed to the
certificate and a copy kept by the notified body.

The certificate
and its annexes shall contain all relevant information to allow the conformity
of manufactured pressure equipment with the examined design to be evaluated and
to allow for in‑service control.

Where the design
does not satisfy the applicable requirements of this Directive, the notified
body shall refuse to issue an EU‑type examination certificate - design
type and shall inform the applicant accordingly, giving detailed reasons for
its refusal.

7.         The
notified body shall keep itself apprised of any changes in the generally
acknowledged state of the art which indicate that the approved design may no
longer comply with the applicable requirements of this Directive, and shall
determine whether such changes require further investigation. If so, the
notified body shall inform the manufacturer accordingly.

The manufacturer
shall inform the notified body that holds the technical documentation relating
to the EU‑type examination certificate - design type of all modifications to the approved
design that may affect the conformity of the pressure equipment with the
essential safety requirements of this Directive or the conditions for validity
of the certificate. Such modifications shall require additional approval in the
form of an addition to the original EU‑type examination certificate ‑ design type.

8.         Each
notified body shall inform its notifying authorities concerning the EU‑type
examination certificates - design type and/or any additions thereto which it
has issued or withdrawn, and shall, periodically or upon request, make
available to its notifying authorities the list of certificates and/or any
additions thereto refused, suspended or otherwise restricted.

Each notified
body shall inform the other notified bodies concerning the EU-type examination
certificates - design type
and/or any additions thereto which it has refused, withdrawn, suspended or
otherwise restricted, and, upon request, concerning the certificates and/or
additions thereto which it has issued.

The Commission,
the Member States and the other notified bodies may, on request, obtain a copy
of the EU-type examination certificates - design type and/or additions thereto. On request, the
Commission and the Member States may obtain a copy of the technical documentation
and the results of the examinations carried out by the notified body. The
notified body shall keep a copy of the EU‑type examination certificate -
design type, its annexes and additions, as well
as the technical file including the documentation submitted by the
manufacturer, until the expiry of the validity of the certificate.

9.         The
manufacturer shall keep a copy of the EU‑type examination certificate -
design type, its annexes and additions together
with the technical documentation at the disposal of the national authorities
for 10 years after the pressure equipment has been placed on the market.

10.       The
manufacturer's authorised representative may lodge the application referred to
in point 3 and fulfil the obligations set out in points 7 and 9, provided that
they are specified in the mandate.

ê 97/23/EC
(adapted)

4. Module C12: (conformity to
type)
Ö based
on internal production control plus supervised pressure equipment checks at
random intervals Õ

ê 97/23/EC

1. This module
describes that part of the procedure whereby the manufacturer, or his
authorized representative established within the Community, ensures and
declares that pressure equipment is in conformity with the type as described in
the EC type-examination certificate and satisfies the requirements of the
Directive which apply to it. The manufacturer, or his authorized representative
established within the Community, must affix the CE marking to each item of
pressure equipment and draw up a written
declaration of conformity.

ò new

1.         Conformity
to type based on internal production control plus supervised pressure equipment
checks at random intervals is the part of a conformity assessment procedure
whereby the manufacturer fulfils the obligations laid down in points 2, 3 and
4, and ensures and declares on his sole responsibility that the pressure
equipment concerned are in conformity with the type described in the EU‑type
examination certificate and satisfy the requirements of this Directive that
apply to it.

ê 97/23/EC
(adapted)

ð new

2. Ö Manufacturing Õ

The manufacturer must Ö shall Õ take all
measures necessary to
ensure Ö so Õ that the
manufacturing process ð and its monitoring ensure conformity
of ï requires
the manufactured pressure equipment to comply with the type as
described in the EC type- Ö EU-type Õ examination
certificate and with the requirements of the Ö this Õ Directive which Ö that Õ apply to it Ö them Õ .

ê 97/23/EC

3. The
manufacturer, or his authorized representative established within the
Community, must keep a copy of the declaration of conformity for a period of
ten years after the last of the pressure equipment has been manufactured.

Where neither the
manufacturer nor his authorized representative is established within the
Community, the obligation to keep the technical documentation available is the
responsibility of the person who places the pressure equipment on the Community
market.

4. Final
assessment must be subject to monitoring in the form of unexpected visits by
a notified body chosen by the manufacturer.

During such
visits, the notified body must:

– 
establish that the
manufacturer actually performs final assessment in accordance with section 3.2
of Annex I,

– 
take samples of
pressure equipment at the manufacturing or storage premises in order to
conduct checks. The notified body must assess the number of items of equipment
to sample and whether it is necessary to perform, or have performed, all or
part of final assessment on the pressure
equipment samples.

Should one or more
of the items of pressure equipment not conform, the notified body must take
appropriate measures.

On the
responsibility of the notified body, the manufacturer must affix the former's
identification number on each item of pressure equipment.

ò new

3.         Final
assessment and pressure equipment checks

A notified body,
chosen by the manufacturer, shall carry out checks or have them carried out at
random intervals determined by the body, in order to verify the quality of the
final assessment and of the internal checks on the pressure equipment, taking
into account inter alia the technological complexity of the pressure equipment
and the quantity of production.

The notified body
shall establish that the manufacturer actually performs final assessment in
accordance with point 3.2 of Annex I.

An adequate
sample of the final pressure equipment, taken on site by the notified body
before the placing on the market, shall be examined and appropriate tests as
identified by the relevant parts of the harmonised standards, and/or equivalent
tests applying other technical specifications, shall be carried out to check
the conformity of the pressure equipment with the relevant requirements of this
Directive.

The notified body
shall assess the number of items of equipment to sample and whether it is
necessary to perform, or have performed, all or part of final assessment on the
pressure equipment samples.

Where a sample
does not conform to the acceptable quality level, the body shall take
appropriate measures.

The acceptance
sampling procedure to be applied is intended to determine whether the
manufacturing process of the pressure equipment performs within acceptable
limits, with a view to ensuring conformity of the pressure equipment.

Where the tests
are carried out by a notified body, the manufacturer shall, under the
responsibility of the notified body, affix the notified body's identification
number during the manufacturing process.

4.         CE marking
and EU declaration of conformity

4.1.      The
manufacturer shall affix the CE marking to each individual pressure equipment
or assembly that is in conformity with the type described in the EU-type
examination certificate and satisfies the applicable requirements of this
Directive.

4.2.      The manufacturer
shall draw up a written EU declaration of conformity for a pressure equipment
model and keep it at the disposal of the national authorities for 10 years
after the pressure equipment has been placed on the market. The EU declaration
of conformity shall identify the pressure equipment model for which it has been
drawn up.

A copy of the EU declaration
of conformity shall be made available to the relevant authorities upon request.

5.         Authorised
representative

The
manufacturer's obligations set out in point 4 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided
that they are specified in the mandate.

ê 97/23/EC
(adapted)

5. Module D: ( Ö conformity
to type based on Õ production
quality assurance) Ö of
the production process Õ

ê 97/23/EC

1. This module
describes the procedure whereby the manufacturer who satisfies the obligations
of section 2 ensures and declares that the pressure equipment concerned is
in conformity with the type described in the EC type-examination certificate or
EC design-examination certificate and satisfies the requirements of the
Directive which apply to it. The manufacturer, or his authorized representative established within the Community,
must affix the CE marking to each item of pressure equipment and draw up a
written declaration of conformity. The CE marking must be accompanied by the
identification number of the notified body responsible for surveillance as
specified in section 4.

ò new

1.         Conformity
to type based on quality assurance of the production process is that part of a
conformity assessment procedure whereby the manufacturer fulfils the
obligations laid down in points 2 and 5, and ensures and declares on his sole
responsibility that the pressure equipment or assembly concerned is in
conformity with the type described in the EU‑type examination certificate
and satisfies the requirements of this Directive that apply to it.

ê 97/23/EC
(adapted)

2. Ö Manufacturing Õ

The manufacturer must Ö shall Õ operate an
approved quality system for production, final Ö product Õ inspection and
testing Ö of the pressure
equipment concerned Õ as specified
in section
point 3 and Ö shall Õ be subject to
surveillance as specified in section point 4.

3. Quality system

3.1. The manufacturer must
Ö shall Õ lodge an
application for assessment of his quality system with a Ö the Õ notified body
of his choice Ö for the
pressure equipment concerned Õ .

The application must Ö shall Õ include:

ò new

– 
the name and address
of the manufacturer and, if the application is lodged by the authorised
representative, his name and address as well;

– 
a written declaration
that the same application has not been lodged with any other notified body;

ê 97/23/EC
(adapted)

ð new

– 
all relevant information on the pressure
equipment ð type envisaged ï concerned,;

– 
the documentation concerning the quality system,;

– 
the technical documentation for Ö of Õ the approved
type and a copy of the EC type- Ö EU-type Õ examination
certificate or EC design-examination certificate.

3.2. The quality system must
Ö shall Õ ensure Ö that Õ compliance of
the pressure equipment Ö is in
conformity Õ with the type
described in the EC
type- Ö EU-type Õ examination
certificate or EC design-examination certificate and
Ö and
comply Õ with the
requirements of the
Ö this Õ Directive which Ö that Õ apply to it.

All the elements, requirements and
provisions adopted by the manufacturer must Ö shall Õ be documented
in a systematic and orderly manner in the form of written policies, procedures
and instructions. This quality system documentation must Ö shall Õ permit a
consistent interpretation of the quality programmes, plans, manuals and
records.

It must Ö shall Õ contain, in particular, Ö contain Õ an adequate
description of:

ê 97/23/EC

– 
the quality objectives and the organizational
structure, responsibilities and powers of the management with regard to the
quality of the pressure equipment,;

ê 97/23/EC
(adapted)

– 
the Ö corresponding Õ manufacturing,
quality control and quality assurance techniques, processes and systematic measures
Ö actions Õ that will be
used, particularly the procedures used for the permanent joining of parts as
approved in accordance with section point 3.1.2 of Annex I,;

ê 97/23/EC

– 
the examinations and tests that will be carried
out before, during and after manufacture, and the frequency with which they will
be carried out,;

ê 97/23/EC
(adapted)

– 
the quality records, such as inspection reports
and test data, calibration data, reports concerning the qualifications or
approvals of the personnel concerned, particularly those of the personnel
undertaking the Ö permanent Õ joining of
parts and the non-destructive tests in accordance with sections
points 3.1.2 and 3.1.3 of Annex I,
Ö etc.
and Õ

ê 97/23/EC

– 
the means of monitoring the achievement of the
required quality and the effective operation of the quality system.

ê 97/23/EC
(adapted)

3.3. The notified body must Ö shall Õ assess the
quality system to determine whether it satisfies the requirements referred to
in 3.2.

ò new

It shall presume
conformity with those requirements in respect of the elements of the quality
system that comply with the corresponding specifications of the national
standard that implements the relevant harmonised standard.

ê 97/23/EC
(adapted)

ð new

The elements of
the quality system which conform to the relevant harmonized standard are
presumed to comply with the corresponding requirements referred to in 3.2.

Ö In
addition to experience in quality management systems, Õ Tthe auditing team must Ö shall Õ have at least
one member with experience of assessing Ö evaluation
in Õ the Ö relevant Õ pressure
equipment Ö field and
pressure equipment Õ technology
concerned ð , and knowledge of the applicable
requirements of this Directive ï . The assessment procedure must Ö audit
shall Õ include an
inspection visit to the manufacturer's premises.

ò new

The auditing team
shall review the technical documentation referred to in point 3.1, fifth
indent, to verify the manufacturer's ability to identify the relevant
requirements of this Directive and to carry out the necessary examinations with
a view to ensuring compliance of the product with those requirements.

ê 97/23/EC
(adapted)

The decision must Ö shall Õ be notified to
the manufacturer. The notification must Ö shall Õ contain the
conclusions of the examination
Ö audit Õ and the
reasoned assessment decision. Provision must be
made for an appeals procedure.

3.4. The manufacturer must Ö shall Õ undertake to
fulfil the obligations arising out of the quality system as approved and to ensure Ö maintain
it so Õ that it
remains satisfactory
Ö adequate Õ and efficient.

3.5. The manufacturer, or his
authorized representative established within the Community, must inform
Ö shall
keep Õ the notified
body that has approved the quality system Ö informed Õ of any intended
adjustment
Ö change Õ to the quality
system.

The notified body must Ö shall Õ assess Ö evaluate Õ the proposed
changes and decide whether the amended Ö modified Õ quality system
will still
Ö continue
to Õ satisfy the
requirements referred to in point 3.2
or whether a reassessment is required Ö necessary Õ .

It must Ö shall Õ notify its decision to
the manufacturer Ö of its
decision Õ. The
notification must
Ö shall Õ contain the
conclusions of the examination and the reasoned assessment decision.

ê 97/23/EC

4. Surveillance under the responsibility of the notified body

4.1. The purpose of surveillance is to make
sure that the manufacturer duly fulfils the obligations arising out of the
approved quality system.

ê 97/23/EC
(adapted)

4.2. The manufacturer must Ö shall,
for assessment purposes, Õ allow the
notified body access for inspection purposes to the locations of manufacture,
inspection, testing and storage Ö sites Õ and Ö shall Õ provide it
with all necessary information, in particular:

– 
the quality system documentation,;

– 
the quality records, such as inspection reports
and test data, calibration data, Ö qualification Õ reports concerning the
qualifications of the personnel concerned, etc.

4.3. The notified body must Ö shall Õ carry out
periodic audits to make sure that the manufacturer maintains and applies the
quality system and provide the manufacturer with an audit report. The frequency
of periodic audits must
Ö shall Õ be such that a
full reassessment is carried out every three years.

4.4. In addition the notified body may pay
unexpected visits to the manufacturer. The need for such additional visits, and
the frequency thereof, will be determined on the basis of a visit control
system operated by the notified body. In particular, the following factors must Ö shall Õ be considered
in the visit control system:

– 
the category of the Ö pressure Õ equipment,;

ê 97/23/EC

– 
the results of previous surveillance visits,;

ê 97/23/EC
(adapted)

– 
the need to follow up corrective action Ö actions Õ ,;

ê 97/23/EC

– 
special conditions linked to the approval of the
system, where applicable,;

– 
significant changes in manufacturing organizsation, policy or techniques.

ê 97/23/EC
(adapted)

During such visits the notified body may,
if necessary, carry out Ö product
tests Õ or have Ö them Õ carried out tests Ö in
order Õ to verify that
the quality system is functioning correctly. The notified body must Ö shall Õ provide the
manufacturer with a visit report and, if a test has taken place
Ö tests
have been carried out Õ , with a test
report.

ò new

5.         CE marking
and EU declaration of conformity

5.1.      The
manufacturer shall affix the CE marking and, under the responsibility of the
notified body referred to in point 3.1, the latter's identification number to
each individual pressure equipment that is in conformity with the type
described in the EU‑type examination certificate and satisfies the
applicable requirements of this Directive.

5.2.      The
manufacturer shall draw up a written EU declaration of conformity for each
pressure equipment model and keep it at the disposal of the national
authorities for 10 years after the pressure equipment has been placed on the
market. The EU declaration of conformity shall identify the pressure equipment
model for which it has been drawn up.

A copy of the EU declaration
of conformity shall be made available to the relevant authorities upon request.

ê 97/23/EC
(adapted)

ð new

56. The manufacturer must Ö shall Õ, for a period of Ö ending Õ ten
10 years after the last of the pressure
equipment has been manufactured
ð placed on the market ï , hold
Ö keep Õ at the
disposal of the national authorities:

ê 97/23/EC

– 
the documentation referred to in
the second indent of point
3.1;

ê 97/23/EC
(adapted)

ð new

– 
the adjustments Ö change Õ referred to in
the
second paragraph of point
3.45 Ö , as
approved Õ ;,

– 
the decisions and reports from Ö of Õ the notified
body which are
referred to in the
last paragraph of points
3.3, the last
paragraph of 3.45, and in 4.3 and 4.4.

67. Each notified body must communicate Ö shall inform Õ to the Member States the relevant information
concerning ð its notifying authorities of ï the quality system approvals which it has
Ö issued
or Õ withdrawn, and
Ö shall Õ ð , periodically or ï , on
Ö upon Õ request, those it has issued ð make available to its notifying
authorities the list of quality system approvals refused, suspended or
otherwise restricted ï .

Each notified body must Ö shall Õ also communicate to
Ö inform Õ the other
notified bodies the
relevant information concerning Ö of Õ the quality
system approvals Ö which Õ it has Ö refused,
suspended, Õ withdrawn or refused
ð otherwise restricted, and, upon
request, of quality system approvals which it has issued ï .

ò new

8.         Authorised
representative

The
manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled
by his authorised representative, on his behalf and under his responsibility,
provided that they are specified in the mandate.

ê 97/23/EC
(adapted)

6. Module
D1: (production
quality assurance) Ö of
the production process Õ

ê 97/23/EC

1. This module
describes the procedure whereby the manufacturer who satisfies the
obligations of section 3 ensures and declares that the items of pressure
equipment concerned satisfy the requirements of the Directive which apply to
them. The manufacturer, or his authorized representative established within the
Community, must affix the CE marking to each
item of pressure equipment and draw up a written declaration of conformity. The
CE marking must be accompanied by the identification number of the notified
body responsible for surveillance as specified in section 5.

ò new

1.         Quality
assurance of the production process is the conformity assessment procedure
whereby the manufacturer fulfils the obligations laid down in points 2, 4 and
7, and ensures and declares on his sole responsibility that the pressure equipment
concerned satisfy the requirements of this Directive that apply to it.

ê 97/23/EC
(adapted)

ð new

2. The
manufacturer must draw up the tTechnical documentation described below.

ð The manufacturer shall establish the
technical documentation. ï The technical
documentation must
Ö shall Õ enable Ö make it
possible to assess Õ an assessment to be made
of the conformity of the pressure equipment with the Ö relevant Õ requirements of the Directive which
apply to it ð and shall include an adequate
analysis and assessment of the risk(s) ï . It
must, ð The technical documentation shall
specify the applicable requirements ï Ö and
cover, Õ as far as is
relevant for such
Ö the Õ assessment, cover
the design, manufacture and operation of the pressure equipment Ö product. The
technical documentation shall, wherever applicable, Õ and Ö contain
at least the following elements Õ :

ê 97/23/EC

– 
a general description of the pressure equipment ,;

ê 97/23/EC
(adapted)

ð new

– 
conceptual design and manufacturing drawings and
diagrams
Ö schemes Õ of components,
sub-assemblies, circuits, etc.,;

– 
descriptions and explanations necessary for an
understanding of the
Ö those Õ said drawings
and diagrams
Ö schemes Õ and the
operation of the pressure equipment ,;

– 
a list of the Ö harmonised Õ standards referred to in Article 5
Ö the
references of which have been published in the Official Journal of the
European Union Õ, applied in
full or in part, and descriptions of the solutions adopted to meet the
essential Ö safety Õ requirements
of the
Ö this Õ Directive
where the
Ö those
harmonised Õ standards referred to in Article 5
have not been applied,. ð In the event of partly applied
harmonised standards, the technical documentation shall specify the parts which
have been applied; ï

– 
results of design calculations made,
examinations carried out, etc., Ö and Õ

– 
test reports.

ò new

3.         The
manufacturer shall keep the technical documentation at the disposal of the
relevant national authorities for 10 years after the pressure equipment has
been placed on the market.

ê 97/23/EC
(adapted)

34. Ö Manufacturing Õ

The manufacturer must Ö shall Õ operate an
approved quality system for production, final Ö product Õ inspection and
testing Ö of the
pressure equipment concerned Õ as specified
in section
4 point 5, and
Ö shall Õ be subject to
surveillance as specified in section 5 point 6.

45. Quality system

45.1. The manufacturer must Ö shall Õ lodge an
application for assessment of his quality system with a Ö the Õ notified body
of his choice Ö for the
pressure equipment concerned Õ .

The application must Ö shall Õ include:

ò new

– 
the name and address
of the manufacturer and, if the application is lodged by the authorised
representative, his name and address as well;

– 
a written declaration
that the same application has not been lodged with any other notified body;

ê 97/23/EC
(adapted)

– 
all relevant information on the pressure
equipment Ö type
envisaged Õ concerned,;

– 
the documentation concerning the quality system.;

ò new

– 
the technical
documentation referred to in point 2.

ê 97/23/EC
(adapted)

45.2. The quality system must Ö shall Õ ensure
compliance of the pressure equipment with the requirements of the Ö this Õ Directive which Ö that Õ apply to it.

All the elements, requirements and
provisions adopted by the manufacturer must Ö shall Õ be documented
in a systematic and orderly manner in the form of written policies, procedures
and instructions. This quality system documentation must Ö shall Õ permit a
consistent interpretation of the quality programmes, plans, manuals and
records.

It must Ö shall, in
particular, Õ contain in particular
an adequate description of:

ê 97/23/EC

– 
the quality objectives and the organizational
structure, responsibilities and powers of the management with regard to the
quality of the pressure equipment,;

ê 97/23/EC
(adapted)

– 
the Ö corresponding Õ manufacturing,
quality control and quality assurance techniques, processes and systematic
measures that will be used, particularly the procedures used for the permanent
joining of parts as approved in accordance with section
point 3.1.2 of Annex I,;

ê 97/23/EC

– 
the examinations and tests that will be carried
out before, during and after manufacture, and the frequency with which they
will be carried out,;

ê 97/23/EC
(adapted)

ð new

– 
the quality records, such as inspection reports
and test data, calibration data, reports concerning the qualifications or
approvals of the personnel concerned, particularly those of the personnel
undertaking the permanent joining of parts in accordance with section
point 3.1.2 of Annex I, Ö etc.; Õ

– 
the means of monitoring the achievement of the
required Ö product Õ quality and
the effective operation of the quality system.

45.3. The notified body must Ö shall Õ assess the
quality system to determine whether it satisfies the requirements referred to
in 45.2. The elements of the quality system
which conform to the relevant harmonised standard are presumed to comply with
the corresponding requirements referred to in 45.2.

Ö In
addition to experience in quality management systems, Õ Tthe auditing team must Ö shall Õ have at least
one member with experience of assessing Ö evaluation
in Õ the pressure
equipment technology concerned ð , and the knowledge of the
applicable requirements of this Directive ï . The assessment
procedure Ö audit Õ must Ö shall Õ include an inspection
Ö assessment Õ visit to the
manufacturer's premises.

ò new

The auditing team
shall review the technical documentation referred to in point 2 in order to
verify the manufacturer's ability to identify the relevant requirements of this
Directive and to carry out the necessary examinations with a view to ensuring
compliance of the pressure equipment with those requirements.

ê 97/23/EC
(adapted)

The decision must Ö shall Õ be notified to
the manufacturer. The notification must Ö shall Õ contain the
conclusions of the examination
Ö audit Õ and the
reasoned assessment decision. Provision must be
made for an appeals procedure.

45.4. The manufacturer must Ö shall Õ undertake to
fulfil the obligations arising out of the quality system as approved and to ensure Ö maintain
it so Õ that it
remains satisfactory
Ö adequate Õ and efficient.

5.5. The manufacturer, or his
authorized representative established within the Community, must inform
Ö shall
keep Õ the notified
body that has approved the quality system Ö informed Õ of any
intended adjustment
Ö change Õ to the quality
system.

The notified body must assess Ö shall
evaluate Õ the Ö any Õ proposed
changes and decide whether the amended Ö modified Õ quality system
will still
Ö continue
to Õ satisfy the
requirements referred to in point 45.2 or whether a reassessment is required
Ö necessary Õ .

If must Ö shall Õ notify its decision to
the manufacturer Ö of its
decision Õ . The
notification must
Ö shall Õ contain the
conclusions of the examination and the reasoned assessment decision.

ê 97/23/EC

56. Surveillance under the
responsibility of the notified body

56.1. The purpose of surveillance is to make sure that the
manufacturer duly fulfils the obligations arising out of the approved quality
system.

ê 97/23/EC
(adapted)

56.2. The manufacturer must Ö shall,
for assessment purposes, Õ allow the
notified body access for inspection purposes to the locations of manufacture, inspection,
testing and storage Ö sites Õ and Ö shall Õ provide it
with all necessary information, in particular:

– 
the quality system documentation,;

ò new

– 
the technical
documentation referred to in point 2;

ê 97/23/EC
(adapted)

– 
the quality records, such as inspection reports
and test data, calibration data, reports concerning the
qualifications
Ö reports Õ of the
personnel concerned, etc.

56.3. The notified body must Ö shall Õ carry out
periodic audits to make sure that the manufacturer maintains and applies the
quality system and provide the manufacturer with an audit report. The frequency
of periodic audits must
Ö shall Õ be such that a
full reassessment is carried out every three years.

56.4. In addition the notified body may pay unexpected visits to the
manufacturer. The need for such additional visits, and the frequency thereof,
will be determined on the basis of a visit control system operated by the
notified body. In particular, the following factors must Ö shall Õ be considered
in the visit control system:

– 
the category of the Ö pressure Õ equipment,;

ê 97/23/EC

– 
the results of previous surveillance visits,;

– 
the need to follow up corrective action(s),;

– 
special conditions linked to the approval of the
system, where applicable,;

– 
significant changes in manufacturing organizsation, policy or techniques.

ê 97/23/EC
(adapted)

During such visits the notified body may,
if necessary, carry out or have carried out Ö product Õ tests Ö , or have
them carried out, in order Õ to verify that
the quality system is functioning correctly. The notified body must Ö shall Õ provide the
manufacturer with a visit report and, if a test has taken place Ö tests have
been carried out Õ , with a test
report.

ò new

7.         CE marking
and EU declaration of conformity

7.1.      The
manufacturer shall affix the CE marking and, under the responsibility of the
notified body referred to in point 5.1, the latter's identification number to
each individual pressure equipment that satisfies the applicable requirements
of this Directive.

7.2.      The
manufacturer shall draw up a written EU declaration of conformity for each
pressure equipment model and keep it at the disposal of the national
authorities for 10 years after the pressure equipment has been placed on the
market. The EU declaration of conformity shall identify the product model for
which it has been drawn up.

A copy of the EU declaration
of conformity shall be made available to the relevant authorities upon request.

ê 97/23/EC
(adapted)

ð new

68. The manufacturer must Ö shall Õ, for a period of Ö ending Õ ten
10 years after the last of the pressure
equipment has been manufactured
ð placed on the market ï , hold
Ö keep Õ at the
disposal of the national authorities:

– 
the technical
documentation referred to in section 2,

ê 97/23/EC

– 
the documentation referred to in the
second indent of point
45.1,;

ê 97/23/EC
(adapted)

ð new

– 
the adjustments Ö change Õ referred to in
the
second paragraph of point 4.45.5,;

– 
the decisions and reports from Ö of Õ the notified
body which are
referred to in the last paragraph of points 4.3, the last paragraph of
4.45.5, and in 56.3 and 56.4.

79. Each notified body must communicate Ö shall
inform Õ to the Member States the relevant information
concerning ð its notifying authorities of ï the quality system approvals which it has
Ö issued
or Õ withdrawn, and
Ö shall Õ ð periodically ï , Ö or Õ on Ö upon Õ request, those it has issued ð make available to its notifying
authorities the list of quality system approvals refused, suspended or
otherwise restricted ï .

Each notified body must also communicate Ö shall inform
Õ to the
other notified bodies the relevant information concerning the Ö of Õ quality system
approvals Ö which Õ it has Ö refused,
suspended, or Õ withdrawn or refused
ð , and upon request, of quality
system approvals which it has issued ï .

ò new

10.       Authorised
representative

The
manufacturer's obligations set out in points 3, 5.1, 5.5, 7 and 8 may be
fulfilled by his authorised representative, on his behalf and under his
responsibility, provided that they are specified in the mandate.

ê 97/23/EC
(adapted)

7. Module
E: (Ö conformity
to type based on Õ product
Ö pressure
equipment Õ quality
assurance)

ê 97/23/EC

1. This module
describes the procedure whereby the manufacturer who satisfies the
obligations of section 2 ensures and declares that the pressure equipment is in
conformity with the type as described in the EC type-examination certificate
and satisfies the requirements of the Directive which apply to it. The manufacturer, or his authorized representative
established within the Community, must affix the CE marking to each product and
draw up a written declaration of conformity. The CE marking must be accompanied
by the identification number of the notified body responsible for
surveillance as specified in section 4.

ò new

1.         Conformity
to type based on pressure equipment quality assurance is that part of a
conformity assessment procedure whereby the manufacturer fulfils the obligations
laid down in points 2 and 5, and ensures and declares on his sole
responsibility that the pressure equipment concerned is in conformity with the
type described in the EU‑type examination certificate and satisfies the
requirements of this Directive that apply to it.

ê 97/23/EC
(adapted)

ð new

2. Ö Manufacturing Õ

The manufacturer must Ö shall Õ operate an
approved quality system for the final pressure equipment Ö product Õ inspection and
testing Ö of the
pressure equipment concerned Õ as specified
in section
point 3 and Ö shall Õ be subject to
surveillance as specified in section point 4.

3. Quality system

3.1. The manufacturer must Ö shall Õ lodge an
application for assessment of his quality system for the pressure equipment with a Ö the Õ notified body
of his choice Ö , for the
pressure equipment concerned Õ.

The application must Ö shall Õ include:

ò new

– 
the name and address
of the manufacturer and, if the application is lodged by the authorised
representative, his name and address as well;

– 
a written declaration
that the same application has not been lodged with any other notified body;

ê 97/23/EC
(adapted)

– 
all relevant information on the pressure
equipment Ö type
envisaged Õ concerned,;

– 
the documentation concerning the quality system
,;

– 
the technical documentation for Ö of Õ the approved
type and a copy of the EC type- Ö EU-type Õ examination
certificate.

3.2. Under the quality
system, each item of pressure equipment must be examined and appropriate
tests as set out in the relevant standard(s) referred to in Article 5, or
equivalent tests, particularly final assessment as referred to in section 3.2
of Annex I, must be carried out in order to
ensure its conformity with the requirements of the Directive which apply to it.

ò new

The quality
system shall ensure compliance of the products with the type described in the EU‑type
examination certificate and with the applicable requirements of this Directive.

ê 97/23/EC
(adapted)

All the elements, requirements and
provisions adopted by the manufacturer must Ö shall Õ be documented
in a systematic and orderly manner in the form of written policies, procedures
and instructions. This quality system documentation must Ö shall Õ permit a
consistent interpretation of the quality programmes, plans, manuals and
records.

It must Ö shall, in
particular, Õ contain in particular
an adequate description of:

– 
the quality objectives and the organizsational structure, responsibilities and
powers of the management with regard to the Ö product Õ quality of the pressure equipment,;

– 
the examinations and tests to Ö that
will Õ be carried out
after manufacture ,;

ê 97/23/EC

– 
the quality records, such as inspection reports
and test data, calibration data, reports concerning the qualifications or
approvals of the personnel concerned, particularly those of the personnel
undertaking the permanent joining of parts and the non-destructive tests in
accordance with sections points
3.1.2 and 3.1.3 of Annex I.;

– 
the means of monitoring the effective operation
of the quality system,.

ê 97/23/EC
(adapted)

ð new

3.3. The notified body must Ö shall Õ assess the
quality system to determine whether it satisfies the requirements referred to
in 3.2. The elements of the quality system which
conform to the relevant harmonized standard are presumed to comply with the
corresponding requirements referred to in 3.2. ð It shall presume conformity with
those requirements in respect of the elements of the quality system that comply
with the corresponding specifications of the national standard that implements
the relevant harmonised standard and/or technical specification. ï

Ö In
addition to experience in quality management systems, Õ Tthe auditing team must Ö shall Õ have at least
one member with experience of assessing Ö evaluation
in the relevant Õ the
pressure equipment Ö field and
pressure equipment Õ technology
concerned ð and knowledge of the applicable
requirements of this Directive ï . The assessment
procedure must Ö audit
shall Õ include an inspection
Ö assessment Õ visit to the
manufacturer's premises.

ò new

The auditing team
shall review the technical documentation referred to in point 3.1, fifth
indent, in order to verify the manufacturer's ability to identify the relevant
requirements of this Directive and to carry out the necessary examinations with
a view to ensuring compliance of the pressure equipment with those
requirements.

ê 97/23/EC
(adapted)

The decision must Ö shall Õ be notified to
the manufacturer. The notification must Ö shall Õ contain the
conclusions of the examination
Ö audit Õ and the
reasoned assessment decision.

3.4. The manufacturer must Ö shall Õ undertake to discharge
Ö fulfil Õ the
obligations arising from
Ö out
of Õ the quality
system as approved and to ensure Ö maintain
it so Õ that it remains
satisfactory
Ö adequate Õ and efficient.

3.5. The manufacturer, or his
authorized representative established within the Community, must inform Ö shall
keep Õ the notified
body which
Ö that Õ has approved
the quality system Ö informed Õ of any
intended adjustment
Ö change Õ to the quality
system.

The notified body must assess Ö shall
evaluate any Õ the
proposed changes and decide whether the modified quality system will still Ö continue
to Õ satisfy the
requirements referred to in point 3.2
or whether a reassessment is required Ö necessary Õ .

It must Ö shall Õ notify its decision to
the manufacturer Ö of its
decision Õ . The
notification must
Ö shall Õ contain the
conclusions of the examination and the reasoned assessment decision.

ê 97/23/EC

4. Surveillance under the responsibility of the notified body

4.1. The purpose of surveillance is to make
sure that the manufacturer duly fulfils the obligations arising out of the
approved quality system.

ê 97/23/EC
(adapted)

4.2. The manufacturer must Ö shall,
for assessment purposes, Õ allow the
notified body access for inspection purposes to the locations of Ö to the
manufacture, Õ inspection,
testing and storage Ö sites Õ and Ö shall Õ provide it
with all necessary information, in particular:

ê 97/23/EC

– 
the quality system documentation,;

– 
the technical documentation,;

– 
the quality records, such as inspection reports
and test data, calibration data, reports concerning the qualifications of the
personnel concerned, etc.

ê 97/23/EC
(adapted)

4.3. The notified body must Ö shall Õ carry out
periodic audits to make sure that the manufacturer maintains and applies the
quality system and provide the manufacturer with an audit report. The frequency
of periodic audits must be such that a full reassessment is carried out every
three years.

ê 97/23/EC

4.4. In addition the notified body may pay
unexpected visits to the manufacturer.

ê 97/23/EC
(adapted)

The need for such additional visits, and
the frequency thereof, will be determined on the basis of a visit control
system operated by the notified body. In particular, the following factors must Ö shall Õ be considered
in the visit control system:

– 
the category of the Ö pressure Õ equipment,;

– 
the results of previous surveillance visits,;

– 
the need to follow up corrective action Ö actions Õ ,;

ê 97/23/EC

– 
special conditions linked to the approval of the
system, where applicable,;

– 
significant changes in manufacturing organizsation, policy or techniques.

ê 97/23/EC
(adapted)

During such visits, the notified body may,
if necessary, carry out or have carried out Ö product Õ tests Ö , or have
them carried out, in order Õ to verify that
the quality system is functioning correctly. The notified body must Ö shall Õ provide the
manufacturer with a visit report and, if a test has taken place
Ö tests
have been carried out Õ , with a test
report.

ò new

5.         CE marking
and EU declaration of conformity

5.1.      The
manufacturer shall affix the CE marking and, under the responsibility of the
notified body referred to in point 3.1, the latter's identification number to
each individual pressure equipment that is in conformity with the type
described in the EU‑type examination certificate and satisfies the
applicable requirements of this Directive.

5.2.      The
manufacturer shall draw up a written EU declaration of conformity for each
pressure equipment model and keep it at the disposal of the national
authorities for 10 years after the pressure equipment has been placed on the
market. The EU declaration of conformity shall identify the product model for
which it has been drawn up.

A copy of the EU declaration
of conformity shall be made available to the relevant authorities upon request.

ê 97/23/EC
(adapted)

ð new

56. The manufacturer must Ö shall Õ, for a period of Ö ending Õ ten
10 years after the last of the pressure
equipment has been manufactured
ð placed on the market ï , hold
Ö keep Õ at the
disposal of the national authorities:

– 
the documentation referred to in the
second indent of point
3.1,;

– 
the adjustments Ö change Õ referred to in
the
second paragraph of point
3.45, Ö as
approved, Õ,;

– 
the decisions and reports from the notified body
which are referred to in the last paragraph of
points 3.3, the
last paragraph of 3.45, and in 4.3 and 4.4.

67. Each notified body must Ö shall Õ communicate to the Member States the relevant
information concerning the ð inform its notifying authorities
of ï quality system approvals which it has Ö issued
or Õ withdrawn and Ö shall Õ ð , periodically or ï , on Ö upon Õ request, those it has issued
ð make available to its notifying
authorities the list of quality system approvals refused, suspended or
otherwise restricted ï .

Each notified body must Ö shall Õ also communicate to
Ö inform Õ the other
notified bodies the
relevant information concerning the Ö of Õ quality system
approvals Ö which Õ it has Ö refused,
suspended or Õ withdrawn ð , and, upon request, of quality
system approvals which it has issued ï or
refused.

ò new

8.         Authorised
representative

The manufacturer's
obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided
that they are specified in the mandate.

ê 97/23/EC
(adapted)

8. Module
E1: (product quality assurance) Ö quality
assurance of final pressure equipment inspection and testing Õ

ê 97/23/EC

1. This module
describes the procedure whereby the manufacturer who satisfies the obligations
of section 3 ensures and declares that the pressure equipment satisfies the
requirements of the Directive which apply to it. The manufacturer, or his
authorized representative established within the Community, must affix the CE
marking to each item of pressure equipment
and draw up a written declaration of conformity. The CE marking must be
accompanied by the identification number of the notified body responsible for
surveillance as specified in section 5.

ò new

1.         Quality
assurance of final pressure equipment inspection and testing is the conformity
assessment procedure whereby the manufacturer fulfils the obligations laid down
in points 2, 4 and 7, and ensures and declares on his sole responsibility that
the pressure equipment concerned satisfy the requirements of this Directive that
apply to it.

ê 97/23/EC
(adapted)

ð new

2. The
manufacturer must draw up the tTechnical documentation described below.

Ö The
manufacturer shall establish the technical documentation. Õ The technical
documentation must
enable Ö shall
make it possible to Õ an
assessment
to be made of
the conformity of the pressure equipment with the Ö relevant Õ requirements ð , and shall include an adequate
analysis and assessment of the risk(s) ï of the
Directive which apply to it. It must Ö The
technical documentation shall specify the applicable requirements and cover Õ , as far
as is
relevant for such
Ö the Õ assessment, cover
the design, manufacture and operation of the pressure equipment. and Ö The
technical documentation shall, wherever applicable, Õ contain Ö at least
the following elements Õ :

– 
a general description of the pressure equipment ,;

– 
conceptual design and manufacturing drawings and
diagrams
Ö schemes Õ of components,
sub-assemblies, circuits, etc.,;

– 
descriptions and explanations necessary for an Ö the Õ understanding
of the
Ö those Õ said
drawings and diagrams
Ö schemes Õ and the
operation of the pressure equipment,;

– 
a list of the Ö harmonised Õ standards referred to in Article 5,
Ö the
references of which have been published in the Official Journal of the
European Union Õ, applied in
full or in part, and descriptions of the solutions adopted to meet the
essential Ö safety Õ requirements
of the
Ö this Õ Directive where
the
Ö those
harmonised Õ standards referred to in Article 5
have not been applied,. ð In the event of partly applied
harmonised standards, the technical documentation shall specify the parts which
have been applied; ï

– 
results of design calculations made,
examinations carried out, etc., Ö and Õ

– 
test reports.

ò new

3.         The
manufacturer shall keep the technical documentation at the disposal of the
relevant national authorities for 10 years after the pressure equipment has
been placed on the market.

ê 97/23/EC
(adapted)

ð new

34. Ö Manufacturing Õ

The manufacturer must Ö shall Õ operate an
approved quality system for the final pressure equipment Ö product Õ inspection and
testing Ö of the
pressure equipment Õ as specified
in section
point 45 and Ö shall Õ be subject to
surveillance as specified in section point 56.

45. Quality system

45.1. The manufacturer must Ö shall Õ lodge an
application for assessment of his quality system with a Ö the Õ notified body
of his choice Ö , for the
pressure equipment concerned Õ .

The application must Ö shall Õ include:

ò new

– 
the name and address
of the manufacturer and, if the application is lodged by the authorised
representative, his name and address as well;

– 
a written declaration that
the same application has not been lodged with any other notified body;

ê 97/23/EC
(adapted)

ð new

– 
all relevant information on the pressure
equipment Ö type
envisaged Õ concerned
,;

– 
the documentation concerning the quality system., Ö and Õ

– 
ð the technical documentation referred
to in point 2. ï

45.2. ð The quality system shall ensure
compliance of the pressure equipment with the requirements of this Directive
that apply to it. ï

Under the quality system, each item of
pressure equipment must
Ö shall Õ be examined
and appropriate tests as set out in the relevant standard(s) referred to in Article
512, or equivalent tests, and
particularly final assessment as referred to in section
point 3.2 of Annex I, must Ö shall Õ be carried out
in order to ensure its conformity with the requirements of the Ö this Õ Directive
which apply to it.

All the elements, requirements and
provisions adopted by the manufacturer must Ö shall Õ be documented
in a systematic and orderly manner in the form of written policies, procedures
and instructions. This quality system documentation must Ö shall Õ permit a
consistent interpretation of the quality programmes, plans, manuals and
records.

It must Ö shall, in
particular, Õ contain in particular
an adequate description of:

ê 97/23/EC

– 
the quality objectives and the organizsational structure, responsibilities and
powers of the management with regard to the quality of the pressure equipment ,;

– 
the procedures used for the permanent joining of
parts as approved in accordance with section point 3.1.2 of Annex I,;

ê 97/23/EC
(adapted)

– 
the examinations and tests to Ö that
will Õ be carried out
after manufacture,;

ê 97/23/EC

– 
the quality records, such as inspection reports
and test data, calibration data, reports concerning the qualifications or
approvals of the personnel concerned, particularly those of the personnel
undertaking the permanent joining of parts in accordance with section
point 3.1.2 of Annex I.;

– 
the means of monitoring the effective operation
of the quality system,.

ê 97/23/EC
(adapted)

ð new

45.3. The notified body must Ö shall Õ assess the
quality system to determine whether it satisfies the requirements referred to
in 45.2.

ð It shall presume conformity with
those requirements in respect of ï Tthe
elements of the quality system which conform to the relevant harmonized standard are presumed to
Ö that Õ comply with
the corresponding requirements
referred to in 4.2 Ö specifications
of the national standard that implements the relevant harmonised standard
and/or technical specification Õ .

Ö In
addition to experience in quality management systems, Õ Tthe auditing team must Ö shall Õ have at least
one member with experience of assessing Ö evaluation
in the relevant Õ the
pressure equipment Ö field and
pressure equipment Õ technology
concerned ð , and knowledge of the applicable
requirements of this Directive ï . The assessment
procedure must Ö audit
shall Õ include an inspection
Ö assessment Õ visit to the
manufacturer's premises.

ò new

The auditing team
shall review the technical documentation referred to in point 2 in order to
verify the manufacturer's ability to identify the relevant requirements of this
Directive and to carry out the necessary examinations with a view to ensuring
compliance of the pressure equipment with those requirements.

ê 97/23/EC (adapted)

ð new

The decision must Ö shall Õ be notified to
the manufacturer. The notification must Ö shall Õ contain the
conclusions of the examination
Ö audit Õ and the
reasoned assessment decision. Provision must be
made for an appeals procedure.

45.4. The manufacturer must Ö shall Õ undertake to discharge
Ö fulfil Õ the
obligations arising from
Ö out
of Õ the quality
system as approved and to ensure Ö maintain
it so Õ that it
remains satisfactory
Ö adequate Õ and efficient.

5.5. The manufacturer, or his
authorized representative established within the Community,
must inform
Ö shall
keep Õ the notified
body which
Ö that Õ has approved
the quality system Ö informed Õ of any
intended adjustment
Ö change Õ to the quality
system.

The notified body must assess the Ö shall
evaluate any Õ proposed
changes and decide whether the modified quality system will still Ö continue
to Õ satisfy the
requirements referred to in point 45.2 or whether a reassessment is
required.

It must Ö shall Õ notify Ö the
manufacturer of Õ its decision to the manufacturer.
The notification must
Ö shall Õ contain the
conclusions of the examination and the reasoned assessment decision.

ê 97/23/EC

56. Surveillance under the
responsibility of the notified body

56.1. The purpose of surveillance is to make sure that the
manufacturer duly fulfils the obligations arising out of the approved quality
system.

ê 97/23/EC
(adapted)

56.2. The manufacturer must Ö shall,
for assessment purposes, Õ allow the
notified body access for inspection purposes to the locations of Ö manufacture, Õ inspection,
testing and storage Ö sites Õ and Ö shall Õ provide it
with all necessary information, in particular:

– 
the quality system documentation
,;

– 
the technical documentation Ö referred
to in point 2 Õ ,;

– 
the quality records, such as inspection reports
and test data, calibration data, Ö qualification Õ reports concerning the
qualifications of Ö on Õ the personnel
concerned, etc.

56.3. The notified body must Ö shall Õ carry out
periodic audits to make sure that the manufacturer maintains and applies the
quality system and provide the manufacturer with an audit report. The frequency
of periodic audits must
Ö shall Õ be such that a
full reassessment is carried out every three years.

56.4. In addition the notified body may pay unexpected visits to the
manufacturer. The need for such additional visits, and the frequency thereof,
will be determined on the basis of a visit control system operated by the
notified body. In particular, the following factors must Ö shall Õ be considered
in the visit control system:

ê 97/23/EC

– 
the category of the equipment ,

– 
the results of previous surveillance visits
,;

– 
the need to follow up corrective action(s) ,;

– 
special conditions linked to the approval of the
system, where applicable ,;

– 
significant changes in manufacturing organizsation, policy or techniques.

ê 97/23/EC
(adapted)

During such visits the notified body may,
if necessary, carry out or have carried out Ö product Õ tests, Ö or have
them carried out, in order Õ to verify that
the quality system is functioning correctly. The notified body must Ö shall Õ provide the
manufacturer with a visit report and, if a test has taken place Ö tests have
been carried out Õ , with a test
report.

ò new

7.         CE marking
and EU declaration of conformity

7.1.      The
manufacturer shall affix the CE marking and, under the responsibility of the
notified body referred to in point 5.1, the latter's identification number
to each individual pressure equipment that satisfies the applicable
requirements of this Directive.

7.2.      The
manufacturer shall draw up a written EU declaration of conformity for each
pressure equipment model and keep it at the disposal of the national
authorities for 10 years after the pressure equipment has been placed on the
market. The EU declaration of conformity shall identify the pressure equipment
model for which it has been drawn up.

A copy of the EU declaration
of conformity shall be made available to the relevant authorities upon request.

ê 97/23/EC
(adapted)

ð new

68. The manufacturer must Ö shall Õ, for a period of Ö ending Õ ten
10 years after the last of the pressure
equipment has been manufactured
ð placed on the market ï , keep at the disposal of the national authorities:

– 
the technical
documentation referred to in section 2,

– 
the documentation referred to in the second indent of
point 45.1,;

– 
the adjustments Ö change Õ referred to in
the
second paragraph of point
4.4
5.5, Ö as
approved; Õ

– 
the decisions and reports from Ö of Õ the notified
body which are
referred to in the last paragraph of 45.3, the last paragraph of
4.45.5, and in 56.3 and 56.4.

79. Each notified body must communicate Ö shall
inform Õ to the Member States the relevant information
concerning the ð its notifying authorities of ï quality system approvals which it has Ö issued or Õ withdrawn and Ö shall Õ ð periodically or ï , on Ö upon Õ request, those is has issued
ð make available to its notifying
authorities the list of quality system approvals refused, suspended or otherwise
restricted ï .

Each notified body must also communicate Ö shall
inform Õ the other
notified bodies the
relevant information concerning the Ö of Õ quality system
approvals Ö which Õ it has Ö refused,
suspended or Õ withdrawn ð , and, upon request, of quality
system approvals which it has issued ï or
refused.

ò new

10.       Authorised
representative

The
manufacturer's obligations set out in points 3, 5.1, 5.5, 7 and 8 may be
fulfilled by his authorised representative, on his behalf and under his
responsibility, provided that they are specified in the mandate.

ê 97/23/EC
(adapted)

ð new

9. Module F: ( Ö conformity
to type based on Õ product
Ö pressure
equipment Õ verification)

1. This module describes the Ö Conformity
to type based on pressure equipment verification is the part of a conformity
assessment Õ procedure
whereby a
Ö the Õ manufacturer, or his authorized representative established
within the Community, ð fulfils the obligations laid down in
points 2 and 5, and ï ensures and declares Ö on his
sole responsibility Õ that the
pressure equipment Ö concerned,
which has been Õ subject to the
provisions of section point
3, is in conformity with the type
described: in the EC type- Ö EU-type Õ examination
certificate, or

– 
in the EC
design-examination certificate

and satisfies the requirements of the Ö this Õ Directive
which apply to it.

2. Ö Manufacturing Õ

The manufacturer must Ö shall Õ take all
measures necessary to
ensure Ö so Õ that the
manufacturing process ð and its monitoring ensure conformity
of the manufactured products ï requires
the pressure equipment to comply with the Ö approved Õ type described
in the EC type- Ö EU-type Õ examination
certificate, or

– 
in the EC
design-examination certificate

and with the requirements of the Ö this Õ Directive
which apply to it
Ö them Õ .

The manufacturer,
or his authorized representative established within the Community, must
affix the CE marking to all pressure equipment and draw up a declaration of
conformity.

3. Ö Verification Õ

The Ö A Õ notified body Ö chosen by
the manufacturer Õ must perform
Ö shall
carry out Õ the
appropriate examinations and tests in order to check the conformity of the
pressure equipment with the relevant ð approved type described in the EU‑type
examination certificate and with the appropriate ï requirements of the Ö this Õ Directive by examining and testing
every product in accordance with section 4.

ê 97/23/EC

The manufacturer,
or his authorized representative established within the Community, must keep
a copy of the declaration of conformity for a period of ten years after the
last of the pressure equipment has been manufactured.

ò new

The examinations
and tests to check the conformity of the pressure equipment with the
appropriate requirements shall be carried out by examination and testing of
every product as specified in point 4.

ê 97/23/EC
(adapted)

ð new

4.
Verification Ö of conformity Õ by examination and testing of each item of
Ö every Õ pressure equipment

4.1. Each item of Ö All Õ pressure
equipment must
Ö shall Õ be
individually examined and must undergo appropriate examinations and tests as set
out in the relevant Ö harmonised Õ standard(s) referred to in Article 5
or equivalent examinations
and tests Ö shall be
carried out Õ in order to
verify that it
conforms to the Ö conformity
with the approved Õ type and ð described in the EU‑type
examination certificate and with the appropriate ï the
requirements of the
Ö this Õ Directive which apply to it.
ð In the absence of such a harmonised
standard, the notified body concerned shall decide on the appropriate tests to
be carried out. ï

In particular, the notified body must Ö shall Õ:

ê 97/23/EC

– 
verify that the personnel undertaking the
permanent joining of parts and the non-destructive tests are qualified or
approved in accordance with sections points 3.1.2 and 3.1.3 of Annex I,;

– 
verify the certificate issued by the materials
manufacturer in accordance with section point 4.3 of Annex I,;

– 
carry out or have carried out the final
inspection and proof test referred to in section point 3.2 of Annex I and examine the
safety devices, if applicable.

ê 97/23/EC
(adapted)

ð new

4.2. The notified body must Ö shall Õ ð issue a certificate of conformity in
respect of the examinations and tests carried out, and ï Ö shall Õ affix its
identification number or have it affixed ð under its responsibility ï to each item
of Ö approved Õ pressure
equipment and draw up a written certificate of conformity
relating to the tests carried out.

ò new

The manufacturer
shall keep the certificates of conformity available for inspection by the
national authorities for 10 years after the pressure equipment has been placed
on the market.

ê 97/23/EC

4.3. The
manufacturer, or his authorized representative established within the
Community, must ensure that the certificates of conformity issued by the
notified body can be made available on request.

ò new

5.         CE marking
and EU declaration of conformity

5.1.      The
manufacturer shall affix the CE marking and, under the responsibility of the
notified body referred to in point 3, the latter's identification number
to each individual pressure equipment that is in conformity with the approved
type described in the EU‑type examination certificate and satisfies the
applicable requirements of this Directive.

5.2.      The
manufacturer shall draw up a written EU declaration of conformity for each
pressure equipment model and keep it at the disposal of the national
authorities, for 10 years after the pressure equipment has been placed on the
market. The EU declaration of conformity shall identify the pressure equipment
model for which it has been drawn up.

A copy of the EU declaration
of conformity shall be made available to the relevant authorities upon request.

If the notified
body referred to in point 3 agrees and under its responsibility, the
manufacturer may also affix the notified body's identification number to the
pressure equipment.

6.         If the
notified body agrees and under its responsibility, the manufacturer may affix
the notified body's identification number to the pressure equipment during the
manufacturing process.

7.         Authorised
representative

The
manufacturer's obligations may be fulfilled by his authorised representative,
on his behalf and under his responsibility, provided that they are specified in
the mandate. An authorised representative may not fulfil the manufacturer's obligations
set out in points 2.

ê 97/23/EC
(adapted)

10. Module
G:

( Ö conformity
based on Õ EC unit
verification)

ê 97/23/EC

1. This module
describes the procedure whereby the manufacturer ensures and declares that
pressure equipment which has been issued with the certificate referred to in
section 4.1 satisfies the requirements of the Directive which apply to it. The
manufacturer must affix the CE marking to the pressure equipment and draw up a
declaration of conformity.

ò new

1.         Conformity
based on unit verification is the conformity assessment procedure whereby the
manufacturer fulfils the obligations laid down in points 2, 3 and 5, and
ensures and declares on his sole responsibility that the pressure equipment
concerned, which has been subject to the provisions of point 4, is in
conformity with the requirements of this Directive that apply to it.

ê 97/23/EC

2. The
manufacturer must apply to a notified body of his choice for unit verification.

The application
must contain:

– 
the name and
address of the manufacturer and the location of the pressure equipment,

– 
a written
declaration to the effect that a similar application has not been lodged with
another notified body,

– 
technical
documentation.

ê 97/23/EC
(adapted)

32. Ö Technical
documentation Õ

ò new

The manufacturer
shall establish the technical documentation and make it available to the
notified body referred to in point 4.

ê 97/23/EC
(adapted)

ð new

The technical documentation must enable
Ö shall
make it possible to assess Õ the conformity
of the pressure equipment with the Ö relevant Õ requirements of the Directive which apply to it to be
assessed
and ð shall include an adequate analysis
and assessment of the risk(s). The technical documentation shall specify the
applicable requirements and cover, as far as relevant for the assessment, ï the design, manufacture and operation of the pressure equipment to be understood.

The technical documentation must Ö shall,
wherever applicable, Õ contain Ö at least
the following elements Õ :

ê 97/23/EC

– 
a general description of the pressure equipment,;

ê 97/23/EC
(adapted)

ð new

– 
conceptual design and manufacturing drawings and
diagrams
Ö schemes Õ of components,
sub-assemblies, circuits, etc.,;

– 
descriptions and explanations necessary for an
understanding of the
Ö those Õ said
drawings and diagrams
Ö schemes Õ and the
operation of the pressure equipment,;

– 
a list of the Ö harmonised Õ standards referred to in Article 5
Ö the
references of which have been published in the Official Journal of the
European Union Õ, applied in
full or in part, and descriptions of the solutions adopted to meet the
essential Ö safety Õ requirements
of the
Ö this Õ Directive
where the
Ö those
harmonised Õ standards, referred to in Article 5 have
not been applied,.
ð In the event of partly applied
harmonised standards, the technical documentation shall specify the parts which
have been applied; ï

– 
results of design calculations made,
examinations carried out, etc.,;

ê 97/23/EC

– 
test reports,;

– 
appropriate details relating to the approval of
the manufacturing and test procedures and of the qualifications or approvals of
the personnel concerned in accordance with sections points 3.1.2 and 3.1.3 of Annex I.

ò new

The manufacturer
shall keep the technical documentation at the disposal of the relevant national
authorities for 10 years after the pressure equipment has been placed on the
market.

3.         Manufacturing

The manufacturer
shall take all measures necessary so that the manufacturing process and its monitoring
ensure conformity of the manufactured pressure equipment with the applicable
requirements of this Directive.

ê 97/23/EC
(adapted)

ð new

4. Ö Verification Õ

The Ö A Õ notified body Ö chosen by
the manufacturer Õ must Ö shall
carry out appropriate examinations Õ examine the design and
construction of each item of pressure equipment and during manufacture perform
appropriate Ö and Õ tests, as set out in the relevant Ö harmonised Õ standard(s) referred to in Article 5 of the Directive,
and/or equivalent examinations
and tests, to ensure its Ö check
the Õ conformity Ö of the
pressure equipment Õ with the Ö applicable Õ requirements
of the
Ö this Õ Directive which apply to it., ð or have them carried out. In the
absence of such a harmonised standard the notified body concerned shall decide
on the appropriate tests to be carried out applying other technical
specifications. ï

In particular the notified body must Ö shall Õ:

ê 97/23/EC

– 
examine the technical documentation with respect
to the design and the manufacturing procedures,;

– 
assess the materials used where these are not in
conformity with the relevant harmonised standards or with a European approval
for pressure equipment materials, and check the certificate issued by the
material manufacturer in accordance with section point 4.3 of Annex I,;

– 
approve the procedures for the permanent joining
of parts or check that they have been previously approved in accordance with section
point 3.1.2 of Annex I,;

– 
verify the qualifications or approvals required
under sections
points 3.1.2 and 3.1.3 of Annex I,;

– 
carry out the final inspection referred to in section
point 3.2.1 of Annex I, perform or
have performed the proof test referred to in section point 3.2.2 of Annex I, and examine the
safety devices, if applicable.

ê 97/23/EC
(adapted)

ð new

4.1. The notified body must Ö shall Õ ð issue a certificate of conformity in
respect of the examinations and tests carried out and ï Ö shall Õ affix its
identification number Ö to the
approved pressure equipment, Õ or have it
affixed to the pressure equipment and draw up a
certificate of conformity for the tests carried out Ö under its
responsibility Õ . This Ö The Õ certificate must be kept for a period of
ð manufacturer shall keep the
certificates of conformity at the disposal of the national authorities
for ï ten 10
years ð after the pressure equipment has
been placed on the market ï .

ê 97/23/EC

4.2. The
manufacturer, or his authorized representative established within the
Community, must ensure that the declaration of conformity and certificate of
conformity issued by the notified body can be made available on request.

ò new

5.         CE marking
and EU declaration of conformity

5.1.      The
manufacturer shall affix the CE marking and, under the responsibility of the
notified body referred to in point 4, the latter's identification number to
each pressure equipment that satisfies the applicable requirements of this
Directive.

5.2.      The
manufacturer shall draw up a written EU declaration of conformity and keep it
at the disposal of the national authorities for 10 years after the pressure
equipment has been placed on the market. The EU declaration of conformity shall
identify the pressure equipment for which it has been drawn up.

A copy of the EU declaration
of conformity shall be made available to the relevant authorities upon request.

6.         Authorised
representative

The
manufacturer's obligations set out in points 2 and 5 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided that they are specified in the
mandate.

ê 97/23/EC
(adapted)

11. Module H: ( Ö conformity
based on Õ full
quality assurance)

ê 97/23/EC

1. This module
describes the procedure whereby the manufacturer who satisfies the obligations
of section 2 ensures and declares that the pressure equipment in question
satisfies the requirements of the Directive which apply to it. The
manufacturer, or his authorized representative established within the
Community, must affix the CE marking to each item of pressure equipment and
draw up a written declaration of conformity. The CE marking must be accompanied by the identification number of
the notified body responsible for surveillance as specified in section 4.

ò new

1.         Conformity
based on full quality assurance is the conformity assessment procedure whereby
the manufacturer fulfils the obligations laid down in points 2 and 5,
and ensures and declares on his sole responsibility that the pressure equipment
concerned satisfies the requirements of this Directive that apply to it.

ê 97/23/EC
(adapted)

2. Ö Manufacturing Õ

The manufacturer must implement Ö shall
operate Õ an approved
quality system for design, manufacture, final Ö product Õ inspection and
testing Ö of the pressure
equipment Õ as specified
in section
point 3 and Ö shall Õ be subject to
surveillance as specified in section point 4.

3. Quality system

3.1. The manufacturer must Ö shall Õ lodge an
application for assessment of his quality system with a Ö the Õ notified body
of his choice, Ö for the
pressure equipment concerned Õ.

The application must Ö shall Õ include:

ê 97/23/EC

– 
all relevant
information concerning the pressure equipment in question,

ò new

– 
the name and address
of the manufacturer and, if the application is lodged by the authorised
representative, his name and address as well;

– 
the technical
documentation for one model of each type of pressure equipment intended to be
manufactured. The technical documentation shall, wherever applicable, contain
at least the following elements:

– 
a general description
of the pressure equipment;

– 
conceptual design and
manufacturing drawings and schemes of components, sub-assemblies, circuits,
etc.;

– 
descriptions and
explanations necessary for the understanding of those drawings and schemes and
the operation of the pressure equipment;

– 
a list of the
harmonised standards the references of which have been published in the Official
Journal of the European Union, applied in full or in part, and descriptions
of the solutions adopted to meet the essential safety requirements of this
Directive where those harmonised standards have not been applied. In the event
of partly applied harmonised standards, the technical documentation shall
specify the parts which have been applied;

– 
results of design
calculations made, examinations carried out, etc.;

– 
test reports;

ê 97/23/EC
(adapted)

– 
the documentation concerning the quality system., Ö and Õ

ò new

– 
a written declaration
that the same application has not been lodged with any other notified body.

ê 97/23/EC
(adapted)

3.2. The quality system must Ö shall Õ ensure
compliance of the pressure equipment with the requirements of the Ö this Õ Directive which Ö that Õ apply to it.

All the elements, requirements and
provisions adopted by the manufacturer must Ö shall Õ be documented
in a systematic and orderly manner in the form of written policies, procedures
and instructions. This
Ö That Õ quality system
documentation must
Ö shall Õ permit a
consistent interpretation of the procedural and quality measures such as
programmes, plans, manuals and records.

It must Ö shall Õ contain
, in particular, Ö contain Õ an adequate
description of:

– 
the quality objectives and the organizsational structure, responsibilities and
powers of the management with regard to the quality of the design and to product
quality,;

– 
the technical design specifications, including
standards, that will be applied and, where the Ö relevant
harmonised Õ standards referred to in Article 5
are Ö will Õ not Ö be Õ applied in
full, the means that will be used to ensure that the essential requirements of the Ö this Õ Directive which Ö that Õ apply to the
pressure equipment will be met,;

ê 97/23/EC
(adapted)

ð new

– 
the design control and design verification
techniques, processes and systematic measures Ö actions Õ that will be
used when designing the pressure equipment, ð pertaining to the product type
covered, ï particularly with regard to materials in accordance with section
point 4 of Annex I,;

– 
the corresponding manufacturing, quality control
and quality assurance techniques, processes and systematic measures
Ö actions Õ that will be
used, particularly the procedures for the permanent joining of parts as
approved in accordance with section point 3.1.2 of Annex I,;

ê 97/23/EC

– 
the examinations and tests to be carried out
before, during, and after manufacture, and the frequency with which they will
be carried out,;

ê 97/23/EC
(adapted)

ð new

– 
the quality records, such as inspection reports
and test data, calibration data, reports concerning the qualifications or
approvals of the personnel concerned, particularly those of the personnel
undertaking the permanent joining of parts and the non-destructive tests in
accordance with sections points
3.1.2 and 3.1.3 of Annex I, Ö etc.; Õ

– 
the means of monitoring the achievement of the
required Ö design
and Õ pressure
equipment design
and quality and the effective operation of the quality
system.

3.3. The notified body must Ö shall Õ assess the
quality system to determine whether it satisfies the requirements referred to
in point 3.2. The elements of the quality system which conform
to the relevant harmonized standard are presumed to comply with the
corresponding requirements referred to in 3.2. ð It shall presume conformity with
those requirements in respect of the elements of the quality system that comply
with the corresponding specifications of the national standard that implements
the relevant harmonised standard and/or technical specification. ï

Ö In
addition to experience in quality management systems, Õ Tthe auditing team must Ö shall Õ have at least
one member with
experience of Ö experienced
as assessor Õ assessing
Ö in Õ the pressure
equipment technology concerned ð , and knowledge of the applicable
requirements of this Directive ï . The assessment
procedure must Ö audit
shall Õ include an inspection
Ö assessment Õ visit to the
manufacturer's premises.

ò new

The auditing team
shall review the technical documentation referred to in point 3.1, second
indent, to verify the manufacturer's ability to identify the applicable
requirements of this Directive and to carry out the necessary examinations with
a view to ensuring compliance of the pressure equipment with those
requirements.

ê 97/23/EC
(adapted)

The Ö manufacturer
or his authorised representative Õ decision must Ö shall Õ be notified Ö of the
decision Õ to the manufacturer.
The notification must
Ö shall Õ contain the
conclusions of the examination
Ö audit Õ and the
reasoned assessment decision. Provision must be made for an appeals procedure.

3.4. The manufacturer must Ö shall Õ undertake to
fulfil the obligations arising out of the quality system as approved and to ensure Ö maintain
it so Õ that it
remains satisfactory
Ö adequate Õ and efficient.

The manufacturer, or his authorized representative established within the Community,
must
inform
Ö shall
keep Õ the notified
body that has approved the quality system Ö informed Õ of any
intended adjustment
Ö change Õ to the quality
system.

The notified body must assess Ö shall
evaluate Õ the Ö any Õ proposed
changes and decide whether the modified quality system will still Ö continue
to Õ satisfy the
requirements referred to in 3.2 or whether a reassessment is required
Ö necessary Õ .

It must Ö shall Õ notify its decision to
the manufacturer Ö of its
decision Õ . The
notification must
Ö shall Õ contain the
conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

4.1. The purpose of this surveillance is to make
sure that the manufacturer duly fulfils the obligations arising out of the
approved quality system.

4.2. The manufacturer must Ö shall,
for assessment purposes, Õ allow the
notified body access for inspection purposes to the locations of design,
manufacture, inspection, testing and storage Ö sites Õ and Ö shall Õ provide it
with all necessary information, in particular:

– 
the quality system documentation,;

– 
the quality records provided for in Ö by Õ the design
part of the quality system, such as results of analyses, calculations, tests,
etc.,;

– 
the quality records provided for in Ö by Õ the
manufacturing part of the quality system, such as inspection reports and test
data, calibration data, Ö qualification Õ reports concerning the
qualifications of Ö on Õ the personnel
concerned, etc.

4.3. The notified body must Ö shall Õ carry out
periodic audits to make sure that the manufacturer maintains and applies the
quality system and Ö shall Õ provide the
manufacturer with an audit report. The frequency of periodic audits must Ö shall Õ be such that a
full reassessment is carried out every three years.

4.4. In addition, the notified body may pay unexpected
visits to the manufacturer.

The need for such additional visits, and
the frequency thereof, will be determined on the basis of a visit control
system operated by the notified body. In particular, the following factors must Ö shall Õ be considered
in the visit control system:

ê 97/23/EC

– 
the category of the equipment,;

– 
the results of previous surveillance visits,;

– 
the need to follow up corrective action(s),;

– 
special conditions linked to the approval of the
system, where applicable,;

– 
significant changes in manufacturing organizsation, policy or techniques.

ê 97/23/EC
(adapted)

ð new

During such visits, the notified body may, if necessary,
carry out or have
carried out Ö product Õ tests Ö , or have
them carried out, in order Õ to verify that the quality
system is Ö check the
proper Õ functioning correctly
Ö of the
quality system Õ . The notified body
Ö It Õ must Ö shall Õ provide the
manufacturer with a visit report and, if a test has taken place Ö tests have
been carried out Õ , with a test
report.

ò new

5.         CE marking
and EU declaration of conformity

5.1.      The
manufacturer shall affix the CE marking and, under the responsibility of the
notified body referred to in point 3.1, the latter's identification number to
each individual pressure equipment that satisfies the applicable requirements
of this Directive.

5.2.      The
manufacturer shall draw up a written EU declaration of conformity for each
pressure equipment model and keep it at the disposal of the national
authorities for 10 years after the pressure equipment has been placed on the market.
The EU declaration of conformity shall identify the pressure equipment model
for which it has been drawn up.

A copy of the EU declaration
of conformity shall be made available to the relevant authorities upon request.

ê 97/23/EC
(adapted)

ð new

56. The manufacturer must Ö shall Õ, for a period of Ö ending Õ ten
10 years after the last of the pressure
equipment has been manufactured
ð placed on the market ï , keep at the disposal of the national authorities:

– 
the Ö technical Õ documentation
referred to in the second indent of the second subparagraph of
point 3.1;

– 
ð the documentation concerning the quality
system referred to in point 3.1; ï

– 
the adjustments Ö change Õ referred to in the second
subparagraph of point
3.4, Ö as
approved Õ ;

– 
the decisions and reports from Ö of Õ the notified
body which are
referred to in the last subparagraph of point 3.3, the
last subparagraph of 3.4, and in 4.3 and 4.4.

67. Each notified body must communicate
to the Member States ð shall inform its notifying authorities
of ï the
relevant information concerning the quality system approvals which it has
Ö issued
or Õ withdrawn, and
ð shall, periodically or ï , on Ö upon Õ request, those it has issued
ð make available to its notifying
authorities the list of quality system approvals refused, suspended or
otherwise restricted ï .

Each notified body must also communicate to Ö shall inform Õ the other
notified bodies the
relevant information concerning the Ö of Õ quality system
approvals Ö which Õ it has Ö refused,
suspended or Õ withdrawn, or refused ð and, upon request, of quality system
approvals which it has issued ï .

ò new

8.         Authorised
representative

The
manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled
by his authorised representative, on his behalf and under his responsibility,
provided that they are specified in the mandate.

ê 97/23/EC
(adapted)

12. Module
H1: (
Ö conformity
based on Õ full
quality assurance with
Ö plus Õ design
examination and
special surveillance of the final assessment)

ê 97/23/EC

1. In addition to
the requirements of module H, the following apply:

(a)        the
manufacturer must lodge an application for examination of the design with the notified body;

(b)        the
application must enable the design, manufacture and operation of the pressure
equipment to be understood, and enable conformity with the relevant
requirements of the Directive to be assessed.

It must include:

– 
the technical
design specifications, including standards, which have been applied,

– 
the necessary
supporting evidence for their adequacy, in particular where the standards
referred to in Article 5 have not been applied in full. This supporting
evidence must include the results of tests carried out by the appropriate
laboratory of the manufacturer or on his behalf;

(c)        the
notified body must examine the application and where the design meets the
provisions of the Directive which apply to it issue an EC design-examination certificate to the applicant. The
certificate must contain the conclusions of the examination, the conditions for
its validity, the necessary data for identification of the approved design and,
if relevant, a description of the functioning of the pressure equipment or
accessories;

(d)        the
applicant must inform the notified body that has issued the EC
design-examination certificate of all modifications to the approved design.
Modifications to the approved design must receive additional approval from the notified body that issued the EC
design-examination certificate where they may affect conformity with the
essential requirements of the Directive or the prescribed conditions for use of
the pressure equipment. This additional approval must be given in the form
of an addition to the original EC design-examination certificate;

(e)        each
notified body must also communicate to the other notified bodies the relevant
information concerning the EC design-examination certificates it has withdrawn
or refused.

2. Final
assessment as referred to in section 3.2 of Annex I is subject to increased
surveillance in the form of unexpected visits by the notified body. In the
course of such visits, the notified body must conduct examinations on the
pressure equipment.

ò new

1.         Conformity
based on full quality assurance plus design examination and special
surveillance of the final assessment is the conformity assessment procedure
whereby the manufacturer fulfils the obligations laid down in points 2 and 6,
and ensures and declares on his sole responsibility that the pressure equipment
concerned satisfy the requirements of the Directive that apply to it.

2.         Manufacturing

The manufacturer
shall operate an approved quality system for design, manufacture and final
product inspection and testing of the products concerned as specified in point
3 and shall be subject to surveillance as specified in point 5. The adequacy of
the technical design of the pressure equipment shall have been examined in
accordance with point 4.

3.         Quality
system

3.1.      The
manufacturer shall lodge an application for assessment of his quality system
with the notified body of his choice, for the pressure equipment concerned.

The application
shall include:

– 
the name and address
of the manufacturer and, if the application is lodged by the authorised
representative, his name and address as well;

– 
the technical
documentation for one model of each type of pressure equipment intended to be
manufactured. The technical documentation shall, wherever applicable, contain
at least the following elements:

– 
a general description
of the pressure equipment;

– 
conceptual design and
manufacturing drawings and schemes of components, sub-assemblies, circuits,
etc.,

– 
descriptions and
explanations necessary for the understanding of those drawings and schemes and
the operation of the pressure equipment;

– 
a list of the
harmonised standards the references of which have been published in the Official
Journal of the European Union, applied in full or in part, and descriptions
of the solutions adopted to meet the essential safety requirements of this
Directive where those harmonised standards have not been applied. In the event
of partly applied harmonised standards, the technical documentation shall
specify the parts which have been applied;

– 
results of design
calculations made, examinations carried out, etc.;

– 
test reports;

– 
the documentation
concerning the quality system;

– 
a written declaration
that the same application has not been lodged with any other notified body.

3.2.      The quality
system shall ensure compliance of the pressure equipment with the requirements
of this Directive that apply to it.

All the elements,
requirements and provisions adopted by the manufacturer shall be documented in
a systematic and orderly manner in the form of written policies, procedures and
instructions. This quality system documentation shall permit a consistent
interpretation of the quality programmes, plans, manuals and records.

It shall, in
particular, contain an adequate description of:

– 
the quality objectives
and the organisational structure, responsibilities and powers of the management
with regard to design and product quality;

– 
the technical design
specifications, including standards, that will be applied and, where relevant
harmonised standards will not be applied in full, the means that will be used
to ensure that the essential safety requirements of the Directive that apply to
the pressure equipment will be met;

– 
the design control and
design verification techniques, processes and systematic actions that will be
used when designing the pressure equipment pertaining to the pressure equipment
type covered, particularly with regard to materials in accordance with point 4
of Annex I;

– 
the corresponding
manufacturing, quality control and quality assurance techniques, processes and
systematic actions that will be used, particularly the procedures for the
permanent joining of parts as approved in accordance with point 3.1.2 of Annex
I;

– 
the examinations and
tests that will be carried out before, during and after manufacture, and the
frequency with which they will be carried out;

– 
the quality records,
such as inspection reports and test data, calibration data, reports concerning
the qualifications or approvals of the personnel concerned, particularly those
of the personnel undertaking the permanent joining of parts and the
non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I,,
etc.;

– 
the means of
monitoring the achievement of the required design and pressure equipment
quality and the effective operation of the quality system.

3.3.      The
notified body shall assess the quality system to determine whether it satisfies
the requirements referred to in point 3.2.

It shall presume
conformity with those requirements in respect of the elements of the quality
system that comply with the corresponding specifications of the national
standard that implements the relevant harmonised standard and/or technical
specifications. In addition to experience in quality management systems, the
auditing team shall have at least one member experienced as an assessor in the
relevant pressure equipment field and pressure equipment technology concerned,
and knowledge of the applicable requirements of this Directive. The audit shall
include an assessment visit to the manufacturer's premises.

The auditing team
shall review the technical documentation referred to in point 3.1, second
indent, to verify the manufacturer's ability to identify the applicable
requirements of this Directive and to carry out the necessary examinations with
a view to ensuring compliance of the pressure equipment with those
requirements.

The manufacturer
or his authorised representative shall be notified of the decision.

The notification
shall contain the conclusions of the audit and the reasoned assessment
decision.

3.4.      The
manufacturer shall undertake to fulfil the obligations arising out of the
quality system as approved and to maintain it so that it remains adequate and
efficient.

3.5.      The
manufacturer shall keep the notified body that has approved the quality system
informed of any intended change to the quality system.

The notified body
shall evaluate any proposed changes and decide whether the modified quality
system will continue to satisfy the requirements referred to in point 3.2 or
whether a re-assessment is necessary.

It shall notify
the manufacturer of its decision. The notification shall contain the
conclusions of the examination and the reasoned assessment decision.

3.6.      Each
notified body shall inform its notifying authorities of quality system
approvals issued or withdrawn, and shall, periodically or upon request, make
available to its notifying authorities the list of quality system approvals
refused, suspended or otherwise restricted.

Each notified
body shall inform the other notified bodies of quality system approvals which
it has refused, suspended or withdrawn, and, upon request, of quality system
approvals which it has issued.

4.         Design
examination

4.1.      The
manufacturer shall lodge an application for examination of the design of each
item of pressure equipment not covered by a previous design examination with
the notified body referred to in point 3.1.

4.2.      The
application shall make it possible to understand the design, manufacture and
operation of the pressure equipment, and to assess the conformity with the
requirements of this Directive that apply to it. It shall include:

– 
the name and address
of the manufacturer;

– 
a written declaration
that the same application has not been lodged with any other notified body;

– 
the technical documentation.
The documentation shall make it possible to assess the conformity of the
pressure equipment with the relevant requirements, and shall include an
adequate analysis and assessment of the risk(s). The technical documentation
shall specify the applicable requirements and cover, as far as relevant for the
assessment, the design and operation of the pressure equipment. The technical
documentation shall, wherever applicable, contain at least the following
elements:

– 
a general description
of the pressure equipment;

– 
conceptual design and
manufacturing drawings and schemes of components, sub-assemblies, circuits,
etc.;

– 
descriptions and
explanations necessary for the understanding of those drawings and schemes and
the operation of the pressure equipment;

– 
a list of the
harmonised standards the references of which have been published in the Official
Journal of the European Union, applied in full or in part, and descriptions
of the solutions adopted to meet the essential safety requirements of this
Directive, where those harmonised standards have not been applied. In the event
of partly applied harmonised standards, the technical documentation shall
specify the parts which have been applied;

– 
results of design
calculations made, examinations carried out, etc., and

– 
test reports;

– 
the supporting
evidence for the adequacy of the technical design. This supporting evidence
shall mention any documents that have been used, in particular where the
relevant harmonised standards have not been applied in full, and shall include,
where necessary, the results of tests carried out by the appropriate laboratory
of the manufacturer or by another testing laboratory on his behalf and under
his responsibility.

4.3.      The
notified body shall examine the application, and where the design meets the
requirements of this Directive that apply to the pressure equipment it shall
issue an EU design examination certificate to the manufacturer. The certificate
shall give the name and address of the manufacturer, the conclusions of the
examination, the conditions (if any) for its validity and the data necessary
for identification of the approved design. The certificate may have one or more
annexes attached.

The certificate
and its annexes shall contain all relevant information to allow the conformity
of manufactured products with the examined design to be evaluated, and to allow
for in-service control, where applicable.

Where the design
does not satisfy the applicable requirements of this Directive, the notified
body shall refuse to issue a design examination certificate and shall inform
the applicant accordingly, giving detailed reasons for its refusal.

4.4.      The
notified body shall keep itself apprised of any changes in the generally
acknowledged state of the art which indicate that the approved design may no
longer comply with the applicable requirements of this Directive, and shall
determine whether such changes require further investigation. If so, the
notified body shall inform the manufacturer accordingly.

The manufacturer
shall keep the notified body that has issued the EU design examination
certificate informed of any modification to the approved design that may affect
the conformity with the essential safety requirements of this Directive or the
conditions for validity of the certificate. Such modifications shall require
additional approval - from the notified body that issued the EU design
examination certificate - in the form of an addition to the original EU design
examination certificate.

4.5.      Each
notified body shall inform its notifying authorities of the EU design
examination certificates and/or any additions thereto which it has issued or
withdrawn, and shall, periodically or upon request, make available to its
notifying authorities the list of certificates and/or any additions thereto
refused, suspended or otherwise restricted.

Each notified
body shall inform the other notified bodies of the EU design examination
certificates and/or any additions thereto which it has refused, withdrawn,
suspended or otherwise restricted, and, upon request, of the certificates
and/or additions thereto which it has issued.

The Commission,
the Member States and the other notified bodies may, on request, obtain a copy
of the EU design examination certificates and/or additions thereto. On request,
the Commission and the Member States may obtain a copy of the technical
documentation and of the results of the examinations carried out by the
notified body.

The notified body
shall keep a copy of the EU design examination certificate, its annexes and
additions, as well as the technical file including the documentation submitted
by the manufacturer until the expiry of the validity of the certificate.

4.6.      The
manufacturer shall keep a copy of the EU design examination certificate, its
annexes and additions together with the technical documentation at the disposal
of the national authorities for 10 years after the pressure equipment has been
placed on the market.

5.         Surveillance
under the responsibility of the notified body

5.1.      The
purpose of surveillance is to make sure that the manufacturer duly fulfils the
obligations arising out of the approved quality system.

5.2.      The
manufacturer shall, for assessment purposes, allow the notified body access to
the design, manufacture, inspection, testing and storage sites, and shall
provide it with all necessary information, in particular:

– 
the quality system
documentation;

– 
the quality records as
provided for by the design part of the quality system, such as results of
analyses, calculations, tests, etc.;

– 
the quality records as
provided for by the manufacturing part of the quality system, such as
inspection reports and test data, calibration data, qualification reports on
the personnel concerned, etc.

5.3.      The
notified body shall carry out periodic audits to make sure that the manufacturer
maintains and applies the quality system and shall provide the manufacturer
with an audit report. The frequency of periodic audits shall be such that a
full reassessment is carried out every three years.

5.4.      In
addition, the notified body may pay unexpected visits to the manufacturer.

The need for such
additional visits, and the frequency thereof, will be determined on the basis
of a visit control system operated by the notified body. In particular, the
following factors must be considered in the visit control system:

– 
the category of the
equipment;

– 
the results of
previous surveillance visits;

– 
the need to follow up
corrective action(s);

– 
special conditions
linked to the approval of the system, where applicable;

– 
significant changes in
manufacturing organisation, policy or techniques.

During such
visits, the notified body may, if necessary, carry out product tests, or have
them carried out, in order to check the proper functioning of the quality
system. It shall provide the manufacturer with a visit report and, if tests
have been carried out, with a test report.

5.5       Special
surveillance of the final assessment

Final assessment
as referred to in section 3.2 of Annex I is subject to increased surveillance
in the form of unexpected visits by the notified body. In the course of such
visits, the notified body shall conduct examinations on the pressure equipment.

It shall provide
the manufacturer with a visit report and, if tests have been carried out, with
a test report.

6.         CE marking
and EU declaration of conformity

6.1.      The
manufacturer shall affix the CE marking and, under the responsibility of the
notified body referred to in point 3.1, the latter's identification number to
each individual pressure equipment that satisfies the applicable requirements
of this Directive.

6.2.      The
manufacturer shall draw up a written EU declaration of conformity for each
pressure equipment model and keep it at the disposal of the national
authorities for 10 years after the pressure equipment has been placed on the
market. The EU declaration of conformity shall identify the pressure equipment
model for which it has been drawn up and shall mention the number of the design
examination certificate.

A copy of the EU declaration
of conformity shall be made available to the relevant authorities upon request.

7.         The
manufacturer shall, for a period ending 10 years after the pressure equipment has
been placed on the market, keep at the disposal of the national authorities:

– 
the documentation
concerning the quality system referred to in point 3.1;

– 
the change referred to
in point 3.5, as approved;

– 
the decisions and
reports of the notified body referred to in points 3.5, 5.3 and 5.4.

8.         Authorised
representative

The
manufacturer's authorised representative may lodge the application referred to
in points 4.1 and 4.2 and fulfil the obligations set out in points 3.1, 3.5,
4.4, 4.6, 6 and 7, on his behalf and under his responsibility, provided that they are specified in the
mandate.

ê 97/23/EC

ANNEX IV

MINIMUM CRITERIA
TO BE MET WHEN DESIGNATING THE NOTIFIED BODIES REFERRED TO IN ARTICLE 12 AND
THE RECOGNIZED THIRD-PARTY ORGANIZATIONS REFERRED TO IN ARTICLE 13

1. The body, its
director and the personnel responsible for carrying out the assessment and
verification operations may not be the designer, manufacturer, supplier,
installer or user of the pressure equipment or assemblies which that body
inspects, nor the authorized representative of any of those parties. They may
not become directly involved in the design, construction, marketing or maintenance of the pressure equipment or
assemblies, nor represent the parties engaged in these activities. This does
not preclude the possibility of exchanges of technical information between the
manufacturer of pressure equipment or assemblies and the notified body.

2. The body and
its personnel must carry out the assessments and verifications with the highest
degree of professional integrity and technical competence and must be free from
all pressures and inducements, particularly financial, which might influence
their judgment or the results of the inspection, especially from persons or
groups of persons with an interest in the results of verifications.

3. The body must
have at its disposal the necessary personnel and possess the necessary
facilities to enable it to perform properly the technical and administrative
tasks connected with the inspection and surveillance operations, it must also
have access to the equipment required to perform special verifications.

4. The personnel
responsible for inspection must have:

– 
sound technical
and vocational training,

– 
satisfactory
knowledge of the requirements of the inspections they carry out and adequate
experience of such operations,

– 
the ability
required to draw up the certificates, records and reports to demonstrate
that the inspections have been carried out.

5. The
impartiality of the inspection personnel must be guaranteed. Their remuneration
must not depend on the number of inspections carried out, nor on the results of
such inspections.

6. The body must
take out liability insurance unless its liability is assumed by the State in
accordance with national law, or the Member State itself is directly
responsible for the inspections.

7. The personnel
of the body must observe professional secrecy with regard to all information
gained in carrying out their tasks (except vis-à-vis the competent
administrative authorities of the State in which their activities are carried
out) under the Directive or any provision of national law giving effect to it.

ANNEX V

CRITERIA TO BE
MET WHEN AUTHORIZING USER INSPECTORATES REFERRED TO IN ARTICLE 14

1. The user
inspectorate must be organizationally identifiable and have reporting methods
within the group of which it is part which ensure and demonstrate its
impartiality. It must not be responsible for
the design, manufacture, supply, installation, operation or maintenance of
the pressure equipment or assemblies, and must not engage in any activities
that might conflict with its independence of judgment and integrity in relation
to its inspection activities.

2. The user
inspectorate and its personnel must carry out the assessments and verifications
with the highest degree of professional integrity and technical competence and
must be free from all pressures and inducements, particularly financial,
which might influence their judgment or the results of the inspection,
especially from persons or groups of persons with an interest in the results of
verifications.

3. The user
inspectorate must have at its disposal the necessary personnel and possess
the necessary facilities to enable it to perform properly the technical and
administrative tasks connected with the inspection and surveillance operations;
it must also have access to the equipment required to perform special
verifications.

4. The
personnel responsible for inspection must have:

– 
sound technical
and vocational training,

– 
satisfactory
knowledge of the requirements of the inspections they carry out and adequate
experience of such operations,

– 
the ability
required to draw up the certificates, records and reports to demonstrate
that the inspections have been carried out.

5. The
impartiality of inspection personnel must be guaranteed. Their remuneration
must not depend on the number of inspections carried out, nor on the results of
such inspections.

6. The user
inspectorate must have adequate liability insurance unless liability is assumed
by the group of which it is part.

7. The personnel
of the user inspectorate must observe professional secrecy with regard to all
information gained in carrying out their tasks (except vis-à-vis the
competent administrative authorities of the State in which their activities are
carried out) under the Directive or any provision of national law giving effect
to it.

ANNEX VI

CE MARKING

The CE marking
consists of the initials «CE» taking the following form:

If the CE marking
is reduced or enlarged the proportions given in the above graduated drawing
must be respected.

The various
components of the CE marking must have substantially the same vertical
dimension, which may not be less than 5 mm.

ê 97/23/EC
(adapted)

ANNEX VIIIV

Ö EU Õ DECLARATION
OF CONFORMITY

The EC Ö EU Õ declaration of
conformity must
Ö shall Õ contain the
following particulars:

ò new

1. No ... (unique
identification of the pressure equipment):

2. Pressure
equipment/pressure equipment model (product, batch, type or serial number):

ê 97/23/EC (adapted)

2.3       nName and address of the manufacturer Ö and,
where applicable, Õ or of
his authorizsed
representative established
within the Community,:

ò new

3. This declaration of conformity is issued under the sole
responsibility of the manufacturer.

4. Object of the
declaration (identification of pressure equipment allowing traceability. It may,
where necessary for the identification of the pressure equipment, include an
image:

ê 97/23/EC
(adapted)

– 
description of the pressure equipment or assembly,;

ê 97/23/EC
(adapted)

– 
conformity assessment procedure followed,;

– 
in the case of assemblies, description of the
pressure equipment constituting the assembly, and the conformity assessment
procedures followed,;

– 
where appropriate, Ö the Õ name,and address Ö and
number Õ of the
notified body which carried out the inspection Ö and the
number of the certificate issued Õ ,;

ê 97/23/EC
(adapted)

– 
where appropriate, a reference to the EC type- Ö EU-type Õ examination
certificate, EC design-
Ö EU-design Õ examination
certificate or EC
Ö EU Õ certificate of
conformity,.

ò new

5. The object of the declaration described above is in
conformity with the relevant Union harmonisation legislation: ................ (reference
to the other Union Directives applied):

6. References to the relevant harmonised standards used or
references to the specifications in relation to which conformity is declared:

ê 97/23/EC

– 
where appropriate,
name and address of the notified body monitoring the manufacturer's quality
assurance system,

ò new

8. Additional information:

Signed for and on behalf of: .........................

(place and date of issue):

(name, function) (signature):

ê 97/23/EC

– 
where appropriate,
the references of the harmonized standards applied,

– 
where appropriate,
other technical standards and specifications used,

ê 97/23/EC
(adapted)

– 
AndÖ where
appropriate, Õ particulars of
the signatory authorized to sign the legally binding declaration for the
manufacturer or his authorizsed representative established within the
Community.

– 
where appropriate, the references of the other
Community Directives applied.

é

ANNEX V

PART A

Repealed Directive with its
successive amendments
(referred to in Article 50)

Directive 97/23/EC of the European Parliament and of the Council || (OJ L 181, 9.7.1997, p.1)

Regulation (EC) No 1882/2003 of the European Parliament and of the Council || (OJ L 284, 31.10.2003, p. 1)

Regulation (EU) No 1025/2012 of the European Parliament and of the Council || (OJ L 316, 14.11.2012, p. 12)

PART B

Time-limits for transposition into
national law and application
(referred to in Article 15)

Directive || Time-limit for transposition || Date of application

97/23/EC || 29 May 1999 || 29 November 1999[45]

ANNEX VI

CORRELATION TABLE

Directive 97/23/EC || This Directive

||

Article 1(1) || Article 1(1)

Article 1(2) || Article 2 (1) to (14)

___ || Article 2 (15) to (31)

Article 1(3) || Article 1(2)

Article 2 || Article 3

Article 3 || Article 4

Article 4 || Article 5

___ || Article 6

___ || Article 7

___ || Article 8

___ || Article 9

___ || Article 10

___ || Article 11

Article 5(1) || Article 12(2)

Article 5(2) || ___

Article 5(3) ||

___ || Article 12(1)

Article 7(1) || Article 40

Article 7(2) || Article 39(1)

___ || Article 39(2)

Article 7(3) || Article 39(3)

Article 7(4) || Article 39(4)

Article 8 || ___

Article 9(1) || Article 13(1) introductory sentence

Article 9(2) point 1 || ____

____ || Article 13(1) (a)

Article 9(2) point 2 || Article 13(1) (b)

Article 9(3) || Article 13(2)

Article 10 || Article 14

Article 11(1) || Article 15(1)

Article 11(2) || Article 15(2)

Article 11(3) || Article 15(3)

Article 11(4) || Article 12(3)

___ || Article 15(4)

Article 11(5) || Article 15(5)

___ || Article 15(6)

Article 12 || ___

Article 13 || ___

Article 14(1) || Article 16(1)

Article 14(2) || Article 5(3)

Article 14(3) to (8) || Article 16(2) to (7)

Article 14(9) and (10) || ___

___ || Article 17

___ || Article 18

Article 15(1) || ___

Article 15(2) || Article 19(1)

Article 15(3) || Article 19(2)

Article 15(4) and (5) || ___

___ || Article 19(3) to (5)

___ || Article 20

___ || Article 21

___ || Article 22

___ || Article 23

___ || Article 24

___ || Article 25

___ || Article 26

___ || Article 27

___ || Article 28

___ || Article 29

___ || Article 30

___ || Article 31

___ || Article 32

___ || Article 33

___ || Article 34

___ || Article 35

___ || Article 36

___ || Article 37

___ || Article 38

Article 16 || ___

Article 17 || ___

Article 18 || ___

___ || Article 41

___ || Article 42

Article 19 || ___

Article 20 (1) to (2) || ___

Article 20(3) || Article 43(1)

___ || Article 43(2) and (3)

___ || Article 44

___ || Article 45

___ || Article 46

Article 21 || Article 47

Annex I || Annex I

Annex II || Annex II

Annex III, introductory wording || Annex III, introductory wording

Annex III, Module A || Annex III, point 1, Module A

Annex III, Module A1 || Annex III, point 2, Module A2

Annex III, Module B || Annex III, point 3.1, Module B, EU-type examination – combination of production type and design type

Annex III, Module B1 || Annex III, point 3.2, Module B, EU-type examination – design type

Annex III, Module C1 || Annex III, point 4, Module C2

Annex III, Module D || Annex III, point 5, Module D

Annex III, Module D1 || Annex III, point 6, Module D1

Annex III, Module E || Annex III, point 7, Module E

Annex III, Module E1 || Annex III, point 8, Module E1

Annex III, Module F || Annex III, point 9, Module F

Annex III, Module G || Annex III, point 10, Module G

Annex III, Module H || Annex III, point 11, Module H

Annex III, Module H1 || Annex III, point 12, Module H1

Annex IV || ____

Annex V || ____

Annex VI || ____

Annex VII || Annex IV

____ || Annex V

____ || Annex VI

[1]               OJ L 353, 31.12.2008, p.1.

[2]               The ‘New Legislative Framework (NLF) Alignment
Package’ of 21 November 2011 consisted of the following nine legislative
proposals : Proposal for a Directive of the European Parliament and of the
Council on the harmonisation of the laws of the Member States relating to the
making available on the market of pyrotechnic articles (COM(2011) 764 final); Proposal
for a Directive of the European Parliament and of the Council on the
harmonisation of the laws of the Member States relating to electromagnetic
compatibility (COM(2011) 765 final); Proposal for a Directive of the European
Parliament and of the Council on the harmonisation of the laws of the Member
States relating to making available on the market of non-automatic weighing
instruments (COM(2011) 766 final); Proposal for a Directive of the European
Parliament and of the Council on the harmonisation of the laws of the Member
States relating to making available on the market of simple pressure vessels
(COM(2011) 768 final); Proposal for a Directive of the European Parliament and
of the Council on the harmonisation of the laws of the Member States relating
to making available on the market of measuring instruments (COM(2011) 769 final);
Proposal for a Directive of the European Parliament and of the Council on the
harmonisation of the laws of the Member States relating to making available on
the market of lifts and safety components for lifts (COM(2011) 770 final); Proposal
for a Directive of the European Parliament and of the Council on the
harmonisation of the laws of the Member States relating to the making available
on the market and supervisions of explosives for civil uses (COM(2011) 771
final); Proposal for a Directive of the European Parliament and of the Council
on the harmonisation of the laws of the Member States relating to equipment and
protective systems intended for use in potentially explosive atmospheres
(COM(2011) 772 final); Proposal for a Directive of the European Parliament and
of the Council on the harmonisation of the laws of Member States relating to
the making available on the market of electrical equipment designed for use
within certain voltage limits (COM(2011)773 final).

[3]               Proposal for a Regulation of the European Parliament
and of the Council on market surveillance of products and amending Council
Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC, 94/25/EC,
95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC,
2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC,
2009/142/EC, 2011/65/EU, Regulation (EU) No 302/2011, Regulation (EC) No
764/2008 and Regulation (EC) No 765/2008 of the European Parliament and of the
Council. COM(2013) 75 final.

[4]               OJ 196, 16.8.1967, p.1.

[5]               According to Article 9 of Directive 97/23/EC, ‘a
dangerous fluid is a substance or preparation covered by the definitions in
Article 2(2) of Council Directive 67/548/EEC’.

[6]               Article 9 of Directive 97/23/EC.

[7]               Communication from the Commission to the European
Parliament, the Council, the Economic and Social Committee and the Committee of
the Regions, COM(2011) 206 final.

[8]               OJ L 316, 14.11.2012, p.12.

[9]               OJ L11, 15.1.2002, p.4.

[10]             Regulation (EU) No 182/2011 of the European Parliament
and of the Council of 16 February 2011 laying down the rules and the general
principles concerning mechanisms for control by Member States of the
Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

[11]             OJ C 77, 28.3.2002, p. 1.

[12]             OJ C [...], [...], p. [...].

[13]             OJ L 181, 9.7.1997, p. 1.

[14]             OJ L 218, 13.8.2008, p. 30.

[15]             OJ L 218, 13.8.2008, p. 82.

[16]             OJ L 260, 30.9.2008, p.13.

[17]             OJ L 165, 30.6.2010, p.1.

[18]             OJ No C
136, 4.6.1985, p. 1.

[19]             OJ No L
220, 8.8.1987, p. 48. Directive as last amended by Directive 93/68/EEC (OJ
No L 220, 30. 8. 1993, p. 1).

[20]             OJ No L
262, 27.9.1976, p. 153. Directive as last
amended by the 1994 Act of Accession.

[21]             OJ 196, 16.8.1967, p. 1.

[22]             OJ L 353, 31.12.2008, p. 1.

[23]             OJ L 316, 14.11.2012, p. 12.

[24]             OJ No
L 109, 26. 4. 1983, p. 8. Directive as
last amended by the 1994 Act of Accession.

[25]             OJ No L
220, 30. 8. 1993, p. 23.

[26]             OJ No C
102, 4. 4. 1996, p. 1.

[27]             OJ L 55, 28.2.2011, p. 13.

[28]             OJ L 264, 8.10.2009,
p. 12     .

[29]             OJ L 147, 9.6.1975, p. 40. Directive
as last amended by Commission Directive 94/1/EC (OJ No L 23, 28. 1. 1994, p.
28).

[30]             OJ L 263, 9.10.2007,
p. 1. OJ No L 42, 23. 2. 1970, p. 1. Directive as last amended by
Commission Directive 95/54/EC (OJ No L 266, 8. 11. 1995, p. 1).

[31]             OJ L 171, 9.7.2003, p. 1. OJ
No L 84, 28. 3. 1974, p. 10. Directive as last amended by the 1994 Act of
Accession.

[32]             OJ L 124, 9.5.2002, p. 1. OJ
No L 225, 10. 8. 1992, p. 72. Directive as last amended by the 1994 Act of
Accession.

[33]             OJ L 157, 9.6.2006, p. 24. OJ
No L 183, 29. 6. 1989, p. 9. Directive as last amended by Directive
93/68/EEC (OJ No L 220, 30. 8. 1993, p. 1).

[34]             OJ L 213, 7.9.1995, p. 1.

[35]             OJ L 374, 27.12.2006, p. 10. OJ
No L 77, 26.3.1973, p. 29. Directive as last amended by Directive 93/68/EEC
(OJ No L 220, 30. 8. 1993, p. 1).

[36]             OJ L 169, 12.7.1993, p. 1.

[37]             OJ L 330, 16.12.2009, p. 10. OJ
No L 196, 26.7.1990, p. 15. Directive
as last amended by Directive 93/68/EEC (OJ No L 220, 30. 8. 1993, p. 1).

[38]             OJ L 100, 19.4.1994, p. 1.

[39]             ADR       = European Agreement concerning the International Carriage of Dangerous Goods by Road.

[40]             RID         = Regulations concerning the International Carriage of
Dangerous Goods by Rail.

[41]             IMDG     = International Maritime Dangerous Goods Code.

[42]             ICAO      = International Civil Aviation Organization.

[43]             OJ
No 196, 16. 8. 1967, p. 1. Directive as last amended by Commission
Directive 94/69/EC (OJ No L 381, 31. 12. 1994, p. 1).

[44]             Council
Decision 1999/468/EC of 28 June 1999 laying down the procedures for the
exercise of implementing powers conferred on the Commission (OJ L 184,
17.7.1999, p. 23).

[45]             In accordance with Article
20(3) of Directive 97/23/EC, Member States shall permit the putting into
service of pressure equipment and assemblies which comply with the regulations
in force in their territory at the date of application of the Directive beyond
that date.